Clinical Trials List
Protocol NumberD4280C00001
2012-09-02 - 2014-08-31
Phase III
Terminated6
ICD-10D18.03
Hemangioma of intra-abdominal structures
A Phase III, Randomized, Multicenter, Double-Blind, Double-Dummy, Parallel-Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime-Avibactam (CAZ-AVI) Plus Metronidazole Versus Meropenem in the Treatment of Complicated Intra-Abdominal Infections (cIAIs) in Hospitalized Adults
-
Trial Applicant
PPD DEVELOPMENT (HK) LIMITED
-
Sponsor
AstraZeneca AB
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 謝奇勳 Division of General Surgery
- Po-Chang Lin Division of Infectious Disease
- 林伯昌 Division of Infectious Disease
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- CHING-CHI Lee Division of General Surgery
- 王志榮 Division of General Surgery
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Hon-Ping Ma Division of Infectious Disease
- 王孝為 Division of Infectious Disease
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Ming-Shun Wu Division of Infectious Disease
- Yung-Fa Chan Division of Infectious Disease
- Wen-Sen Lee Division of Infectious Disease
- Chih-Shiang Chang Division of Infectious Disease
- Fat-Moon Suk Division of Infectious Disease
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Complicated Intra-Abodominal Infections (cIAIs)
Objectives
The primary objective of this study is:
• To assess the noninferiority of CAZ-AVI plus metronidazole compared to
meropenem with respect to clinical cure at TOC visit in patients who have at least 1
identified pathogen.
The secondary objectives of this study are
• To determine the efficacy of CAZ-AVI plus metronidazole compared to
meropenem with respect to clinical cure at TOC in patients who are ME
• To determine the efficacy of CAZ-AVI plus metronidazole compared to
meropenem with respect to the clinical cure at End of Treatment (EOT) with IV
therapy, and at Late Follow-Up (LFU) both in patients who have at least 1
identified pathogen and in patients who are ME
• To determine the efficacy of CAZ-AVI plus metronidazole compared to
meropenem with respect to clinical cure at EOT, TOC, and LFU in patients who are
clinically evaluable (CE)
• To determine the per-patient and per-pathogen microbiologic response of CAZ-AVI
plus metronidazole compared to meropenem at EOT, TOC, and LFU both in
patients who have at least 1 identified pathogen and in patients who are ME
• To evaluate the efficacy of CAZ-AVI plus metronidazole versus meropenem in
pathogens resistant to ceftazidime.
• To compare the time to first defervescence of CAZ-AVI plus metronidazole versus
meropenem in patients who are on IV study therapy and who have fever at study
entry both in patients who are CE and in patients who are ME
• To evaluate the safety and tolerability profile of CAZ-AVI plus metronidazole
compared to meropenem in the treatment of patients with cIAIs in the safety
analysis set
• To evaluate the pharmacokinetics of the individual components of CAZ-AVI
(avibactam and ceftazidime) in patients with cIAIs
• To evaluate CAZ-AVI exposure and the antimicrobial response relationship in
patients with cIAIs.
Test Drug
CAZ104 (Ceftazidime avibactam)
Active Ingredient
Avibactam
Ceftazidime
Ceftazidime
Dosage Form
Injection/ vials
Dosage
2000 mg
500 mg
500 mg
Endpoints
Primary efficacy variable
The primary efficacy outcome variable is the proportion of patients with clinical
cure at the TOC visit in the microbiological modified intent-to-treat (mMITT)
analysis set.
Secondary efficacy variables
The secondary efficacy outcome variables include the following:
− Proportion of patients with clinical cure at the TOC visit in the ME and
extended ME analysis sets
− Proportion of patients with clinical cure at the EOT and LFU visits in the
mMITT, ME, and extended ME analysis sets
− Proportion of patients with clinical cure at EOT, TOC, and LFU in the CE
analysis set
− Proportion of patients with a favorable per-patient microbiological response at
the EOT, TOC, and LFU visits in the mMITT, ME, and extended ME analysis
sets
− Proportion of favorable per-pathogen microbiological response at the EOT,
TOC, and LFU visits in the mMITT, ME, and extended ME analysis sets
− Favorable per-pathogen microbiologic response at the EOT, TOC, and LFU
visits by minimum inhibitory concentration (MIC) categories in the mMITT,
ME, and extended ME analysis sets
− Favorable per-patient clinical response and favorable per-patient
microbiological response at the TOC visit for patients infected with
ceftazidime-resistant pathogens in the mMITT, ME, and extended ME analysis
sets
− Proportion of patients with a favorable per-pathogen microbiological response
at the TOC visit for patients infected with ceftazidime-resistant pathogens in
the mMITT, ME, and extended ME analysis sets
− Time to first defervescence while on IV study therapy in the CE, ME, and
extended ME analysis sets for patients who have fever at study entry.
The primary efficacy outcome variable is the proportion of patients with clinical
cure at the TOC visit in the microbiological modified intent-to-treat (mMITT)
analysis set.
Secondary efficacy variables
The secondary efficacy outcome variables include the following:
− Proportion of patients with clinical cure at the TOC visit in the ME and
extended ME analysis sets
− Proportion of patients with clinical cure at the EOT and LFU visits in the
mMITT, ME, and extended ME analysis sets
− Proportion of patients with clinical cure at EOT, TOC, and LFU in the CE
analysis set
− Proportion of patients with a favorable per-patient microbiological response at
the EOT, TOC, and LFU visits in the mMITT, ME, and extended ME analysis
sets
− Proportion of favorable per-pathogen microbiological response at the EOT,
TOC, and LFU visits in the mMITT, ME, and extended ME analysis sets
− Favorable per-pathogen microbiologic response at the EOT, TOC, and LFU
visits by minimum inhibitory concentration (MIC) categories in the mMITT,
ME, and extended ME analysis sets
− Favorable per-patient clinical response and favorable per-patient
microbiological response at the TOC visit for patients infected with
ceftazidime-resistant pathogens in the mMITT, ME, and extended ME analysis
sets
− Proportion of patients with a favorable per-pathogen microbiological response
at the TOC visit for patients infected with ceftazidime-resistant pathogens in
the mMITT, ME, and extended ME analysis sets
− Time to first defervescence while on IV study therapy in the CE, ME, and
extended ME analysis sets for patients who have fever at study entry.
Inclution Criteria
1. Subject must provide a signed written informed consent prior to any study-specific procedures.
2. Subject must be 18 to 90 years of age inclusive. In Taiwan, the minimum age is 20 years.
3. Subject are female and are authorized to participate in this clinical study if subject meet the
following criteria:
(a) Have been surgically sterilized or postmenopausal for at least 1 year or subjectr sexual
partner has had a vasectomy
OR
(b) Is of childbearing potential and all of the following conditions are met:
Have had normal menstrual periods for the 3 months prior to study entry, and
Have a negative serum pregnancy test (serum ß-human chorionic gonadotropin
[ß-hCG]) within 1 day prior to study entry (if the results of the serum ß-hCG cannot be
obtained prior to dosing of the investigational product (IP), a patient may be enrolled on
the basis of a negative urine pregnancy test, though serum ß-hCG must still be
obtained), and
Must be willing, during treatment and for at least 7 days after last dose of IV study
therapy, to practice highly effective methods of birth control, such as intrauterine device
(with copper banded coil), levonorgestrel intrauterine system (eg, Mirena®), and
medroxyprogesterone injections (Depo-Provera®), or remain sexually abstinent. Oral
contraceptives should not be used as the sole method of birth control because the effect
of CAZ-AVI on the efficacy of oral contraceptives has not yet been established.
Barrier methods (such as male condom or diaphragm with spermicide) can be used if
another method of acceptable contraception (not oral contraceptives) is also used.
4. EITHER:
Intra-operative/postoperative enrollment with visual confirmation (presence of pus within the
abdominal cavity) of an intra-abdominal infection associated with peritonitis. Surgical
intervention includes open laparotomy, percutaneous drainage of an abscess, or laparoscopic
surgery. Specimens from the surgical intervention must be sent for culture.
Subject undergo a surgical procedure with complete fascial closure are appropriate for the trial.
The skin incision may be left open for purposes of wound management as long as complete
fascial closure is accomplished. Subject have at least 1 of the following diagnosed during the
surgical intervention:
(a) Cholecystitis with gangrenous rupture or perforation or progression of the infection beyond
the gallbladder wall
(b) Diverticular disease with perforation or abscess
(c) Appendiceal perforation or peri-appendiceal abscess
(d) Acute gastric or duodenal perforations, only if operated on >24 hours after perforation
occurs
(e) Traumatic perforation of the intestines, only if operated on >12 hours after perforation
occurs
(f) Secondary peritonitis (but not spontaneous bacterial peritonitis associated with cirrhosis and
chronic ascites)
(g) Intra-abdominal abscess (including of liver or spleen provided that there is extension beyond
the organ with evidence of intraperitoneal involvement)
OR
Preoperative enrollment where the following clinical criteria are met with confirmation of
infection by surgical intervention within 24 hours of entry:
(a) Requirement for surgical intervention, defined per protocol as open laparotomy,
percutaneous drainage of an abscess, or laparoscopic surgery
(b) Evidence of systemic inflammatory indicators, with at least 1 of the following:
- Fever (defined as body temperature >38°C) or hypothermia with a core body
o temperature <35°C
- Elevated white blood cell count (>12000 cells/mm3
)
- Drop in blood pressure (BP) (however, systolic BP must be >90 mm Hg without pressor
support)
- Increased heart rate( >90 bpm) and respiratory rate (RR) (>20 breaths/min)
- Hypoxia
- Altered mental status.
(c) Physical findings consistent with intra-abdominal infection, such as:
- Abdominal pain and/or tenderness, with or without rebound
- Localized or diffuse abdominal wall rigidity
- Abdominal mass.
(d) Supportive radiologic imaging findings of intra-abdominal infection such as perforated
intraperitoneal abscess detected on computed tomography scan, magnetic resonance image,
or ultrasound.
(e) Specimens from the surgical intervention will be sent for culture.
2. Subject must be 18 to 90 years of age inclusive. In Taiwan, the minimum age is 20 years.
3. Subject are female and are authorized to participate in this clinical study if subject meet the
following criteria:
(a) Have been surgically sterilized or postmenopausal for at least 1 year or subjectr sexual
partner has had a vasectomy
OR
(b) Is of childbearing potential and all of the following conditions are met:
Have had normal menstrual periods for the 3 months prior to study entry, and
Have a negative serum pregnancy test (serum ß-human chorionic gonadotropin
[ß-hCG]) within 1 day prior to study entry (if the results of the serum ß-hCG cannot be
obtained prior to dosing of the investigational product (IP), a patient may be enrolled on
the basis of a negative urine pregnancy test, though serum ß-hCG must still be
obtained), and
Must be willing, during treatment and for at least 7 days after last dose of IV study
therapy, to practice highly effective methods of birth control, such as intrauterine device
(with copper banded coil), levonorgestrel intrauterine system (eg, Mirena®), and
medroxyprogesterone injections (Depo-Provera®), or remain sexually abstinent. Oral
contraceptives should not be used as the sole method of birth control because the effect
of CAZ-AVI on the efficacy of oral contraceptives has not yet been established.
Barrier methods (such as male condom or diaphragm with spermicide) can be used if
another method of acceptable contraception (not oral contraceptives) is also used.
4. EITHER:
Intra-operative/postoperative enrollment with visual confirmation (presence of pus within the
abdominal cavity) of an intra-abdominal infection associated with peritonitis. Surgical
intervention includes open laparotomy, percutaneous drainage of an abscess, or laparoscopic
surgery. Specimens from the surgical intervention must be sent for culture.
Subject undergo a surgical procedure with complete fascial closure are appropriate for the trial.
The skin incision may be left open for purposes of wound management as long as complete
fascial closure is accomplished. Subject have at least 1 of the following diagnosed during the
surgical intervention:
(a) Cholecystitis with gangrenous rupture or perforation or progression of the infection beyond
the gallbladder wall
(b) Diverticular disease with perforation or abscess
(c) Appendiceal perforation or peri-appendiceal abscess
(d) Acute gastric or duodenal perforations, only if operated on >24 hours after perforation
occurs
(e) Traumatic perforation of the intestines, only if operated on >12 hours after perforation
occurs
(f) Secondary peritonitis (but not spontaneous bacterial peritonitis associated with cirrhosis and
chronic ascites)
(g) Intra-abdominal abscess (including of liver or spleen provided that there is extension beyond
the organ with evidence of intraperitoneal involvement)
OR
Preoperative enrollment where the following clinical criteria are met with confirmation of
infection by surgical intervention within 24 hours of entry:
(a) Requirement for surgical intervention, defined per protocol as open laparotomy,
percutaneous drainage of an abscess, or laparoscopic surgery
(b) Evidence of systemic inflammatory indicators, with at least 1 of the following:
- Fever (defined as body temperature >38°C) or hypothermia with a core body
o temperature <35°C
- Elevated white blood cell count (>12000 cells/mm3
)
- Drop in blood pressure (BP) (however, systolic BP must be >90 mm Hg without pressor
support)
- Increased heart rate( >90 bpm) and respiratory rate (RR) (>20 breaths/min)
- Hypoxia
- Altered mental status.
(c) Physical findings consistent with intra-abdominal infection, such as:
- Abdominal pain and/or tenderness, with or without rebound
- Localized or diffuse abdominal wall rigidity
- Abdominal mass.
(d) Supportive radiologic imaging findings of intra-abdominal infection such as perforated
intraperitoneal abscess detected on computed tomography scan, magnetic resonance image,
or ultrasound.
(e) Specimens from the surgical intervention will be sent for culture.
Exclusion Criteria
1. Subject are diagnosed with traumatic bowel perforation undergoing surgery within 12 hours;
perforation of gastroduodenal ulcers undergoing surgery within 24 hours. Other intra-abdominal
processes in which the primary etiology is not likely to be infectious.
2. Subject have abdominal wall abscess or bowel obstruction without perforation or ischemic
bowel without perforation.
3. Subject has simple cholecystitis, or gangrenous cholecystitis without rupture, or simple
appendicitis, or acute suppurative cholangitis; or infected necrotizing pancreatitis or pancreatic
abscess.
4. Subject are surgery will include staged abdominal repair, or “open abdomen” technique, or
marsupialization. This criterion is intended to exclude patients in whom the abdomen is left
open, particularly those for whom reoperation is planned.
5. Subject are known at study entry to have a cIAI (complicated Intra-Adbominal Infections)
caused by pathogens resistant to the study antimicrobial agents.
6. Subject need effective concomitant systemic antibacterials (oral, IV, or intramuscular) or
antifungals in addition to those designated in the 2 study groups, except vancomycin, linezolid,
or daptomycin if started for known or suspected methicillin-resistant Staphylococcus aureus
(MRSA) or Enterococcus species.
7. Subject have perinephric infections
8. Subject have indwelling peritoneal dialysis catheter.
9. Subject have suspected intra-abdominal infections due to fungus, parasites (eg, amebic liver
abscess), virus, or tuberculosis.
10. Subject have a known history of serious allergy, hypersensitivity (eg, anaphylaxis), or any
serious reaction to carbapenem or cephalosporin antibiotics or other β lactam antibiotics or
metronidazole.
11. Subject have any of the following laboratory values as defined below:
(a) Estimated creatinine clearance ≤30 mL/min calculated by Cockcroft-Gault method
(b) Hematocrit <25% or hemoglobin <8 g/dL
(c) Absolute neutrophil count <1000/mm3
(d) Platelet count <75000/mm3
(e) Bilirubin >3 × the upper limit of normal (ULN), unless isolated hyperbilirubinemia is
directly related to the acute infection or known Gilbert’s disease
(f) ALT or AST >3 × ULN values at Screening. Subject with elevations of AST and/or ALT up
to 5 × ULN are eligible if these elevations are acute and directly related to the infectious
process being treated. This must be documented.
(g) Alkaline phosphatase >3 × ULN. Subject with values >3.0 × ULN and <5.0 × ULN are
eligible if this value is acute and directly related to the infectious process being treated. This
must be documented.
12. Subject have a body mass index >45 kg/m2.
13. Subject have APACHE II score >30
* APACHE II, Acute Physiology and Chronic Health Evaluation II, is a severity-of-disease
classification system.
14. Subject are considered unlikely to survive the 6- to 8-week study period or has a rapidly
progressive or terminal illness, including septic shock that is associated with a high risk of
mortality.
15. Subject are unlikely to respond to 5 to 14 days of treatment with antibiotics.
16. Subject have received systemic antibacterial agents within the 72-hour period prior to study
entry, unless either of the following pertains:
(a) Subject have a new infection (not considered a treatment failure) and both of the following are
met:
- Subject received no more than 24 hours of total prior antibiotic therapy
- Subject received ≤1 dose of a treatment regimen postoperatively and antibiotics were not
received more than 6 hours postprocedure (defined as 6 hours from the time of skin closure
or, if skin closure is not performed, 6 hours from the time the wound dressing is applied)
(b) Subject are considered to have failed the previous treatment regimen. In this case, preoperative
treatment of any duration with nonstudy systemic antimicrobial therapy for peritonitis or
abscess is permitted provided that all of the following are met:
- The treatment regimen has been administered for at least 72 hours and is judged to have
been inadequate.
- Subject had an operative intervention that is just completed or is intended no more than 24
hours after study entry.
- Findings of infection were documented at surgery.
- Specimens for bacterial cultures and susceptibility testing are taken at operative
intervention
- No further nonstudy antibacterials are administered after randomization.
17. Subject have a concurrent infection that may interfere with the evaluation of response to the
study antibiotic.
18. Subject are receiving hemodialysis or peritoneal dialysis.
19. Subject have a history of acute hepatitis, chronic hepatitis, cirrhosis, acute hepatic failure, or
acute decompensation of chronic hepatic failure.
20. Subject have past or current history of epilepsy or seizure disorders excluding febrile seizures
of childhood.
* Febrile seizures is a type of convulsion associated with a significant rise in body temperature.
They most commonly occur in children.
21. Subject are immunocompromised as evidenced by any of the following:
(a) Human immunodeficiency virus infection, with either a current acquired immune deficiency
syndrome-defining condition (eg, Kaposi’s sarcoma, Pneumocystis carinii pneumonia) or a
CD4 + T lymphocyte count <200/mm3 at the time of study entry
(b) Metastatic or hematological malignancy requiring chemotherapeutic interventions within 6
weeks prior to randomization
(c) Immunosuppressive therapy, including maintenance corticosteroid therapy (>40 mg/day
equivalent prednisolone).
22. Subject are participating in any other clinical study that involves the administration of an
investigational medication at the time of presentation, during the course of the study, or have
received treatment with an investigational medication in the 30 days prior to study enrollment.
23. Subject are in a situation or have a condition that, in the investigator’s opinion, may interfere
with optimal participation in the study.
24. Subject are unlikely to comply with protocol, eg, uncooperative attitude, inability to return for
follow-up visits, and unlikely to complete the study.
25. Subject have previously been treated with CAZ-AVI.
26. Subject have known inflammatory bowel disease (ulcerative colitis or Crohn’s disease).
27. Subject have known C. difficile-associated diarrhea.
28. Subject had been previously enrolled in this study.
29. Subject are pregnant or breastfeeding. A serum β- hCG pregnancy test must be sent for
women of childbearing potential at the screening visit. If the results of the serum β-hCG
cannot be obtained prior to dosing of IP, a patient may be enrolled on the basis of a
negative urine pregnancy test, though serum β-hCG must still be obtained. If either test is
positive, the patient must be excluded. Since urine and serum tests may miss a pregnancy
in the first days after conception, relevant sexual history, including methods of
contraception should be considered. Any patient whose sexual history suggests the
possibility of early pregnancy must be excluded.
perforation of gastroduodenal ulcers undergoing surgery within 24 hours. Other intra-abdominal
processes in which the primary etiology is not likely to be infectious.
2. Subject have abdominal wall abscess or bowel obstruction without perforation or ischemic
bowel without perforation.
3. Subject has simple cholecystitis, or gangrenous cholecystitis without rupture, or simple
appendicitis, or acute suppurative cholangitis; or infected necrotizing pancreatitis or pancreatic
abscess.
4. Subject are surgery will include staged abdominal repair, or “open abdomen” technique, or
marsupialization. This criterion is intended to exclude patients in whom the abdomen is left
open, particularly those for whom reoperation is planned.
5. Subject are known at study entry to have a cIAI (complicated Intra-Adbominal Infections)
caused by pathogens resistant to the study antimicrobial agents.
6. Subject need effective concomitant systemic antibacterials (oral, IV, or intramuscular) or
antifungals in addition to those designated in the 2 study groups, except vancomycin, linezolid,
or daptomycin if started for known or suspected methicillin-resistant Staphylococcus aureus
(MRSA) or Enterococcus species.
7. Subject have perinephric infections
8. Subject have indwelling peritoneal dialysis catheter.
9. Subject have suspected intra-abdominal infections due to fungus, parasites (eg, amebic liver
abscess), virus, or tuberculosis.
10. Subject have a known history of serious allergy, hypersensitivity (eg, anaphylaxis), or any
serious reaction to carbapenem or cephalosporin antibiotics or other β lactam antibiotics or
metronidazole.
11. Subject have any of the following laboratory values as defined below:
(a) Estimated creatinine clearance ≤30 mL/min calculated by Cockcroft-Gault method
(b) Hematocrit <25% or hemoglobin <8 g/dL
(c) Absolute neutrophil count <1000/mm3
(d) Platelet count <75000/mm3
(e) Bilirubin >3 × the upper limit of normal (ULN), unless isolated hyperbilirubinemia is
directly related to the acute infection or known Gilbert’s disease
(f) ALT or AST >3 × ULN values at Screening. Subject with elevations of AST and/or ALT up
to 5 × ULN are eligible if these elevations are acute and directly related to the infectious
process being treated. This must be documented.
(g) Alkaline phosphatase >3 × ULN. Subject with values >3.0 × ULN and <5.0 × ULN are
eligible if this value is acute and directly related to the infectious process being treated. This
must be documented.
12. Subject have a body mass index >45 kg/m2.
13. Subject have APACHE II score >30
* APACHE II, Acute Physiology and Chronic Health Evaluation II, is a severity-of-disease
classification system.
14. Subject are considered unlikely to survive the 6- to 8-week study period or has a rapidly
progressive or terminal illness, including septic shock that is associated with a high risk of
mortality.
15. Subject are unlikely to respond to 5 to 14 days of treatment with antibiotics.
16. Subject have received systemic antibacterial agents within the 72-hour period prior to study
entry, unless either of the following pertains:
(a) Subject have a new infection (not considered a treatment failure) and both of the following are
met:
- Subject received no more than 24 hours of total prior antibiotic therapy
- Subject received ≤1 dose of a treatment regimen postoperatively and antibiotics were not
received more than 6 hours postprocedure (defined as 6 hours from the time of skin closure
or, if skin closure is not performed, 6 hours from the time the wound dressing is applied)
(b) Subject are considered to have failed the previous treatment regimen. In this case, preoperative
treatment of any duration with nonstudy systemic antimicrobial therapy for peritonitis or
abscess is permitted provided that all of the following are met:
- The treatment regimen has been administered for at least 72 hours and is judged to have
been inadequate.
- Subject had an operative intervention that is just completed or is intended no more than 24
hours after study entry.
- Findings of infection were documented at surgery.
- Specimens for bacterial cultures and susceptibility testing are taken at operative
intervention
- No further nonstudy antibacterials are administered after randomization.
17. Subject have a concurrent infection that may interfere with the evaluation of response to the
study antibiotic.
18. Subject are receiving hemodialysis or peritoneal dialysis.
19. Subject have a history of acute hepatitis, chronic hepatitis, cirrhosis, acute hepatic failure, or
acute decompensation of chronic hepatic failure.
20. Subject have past or current history of epilepsy or seizure disorders excluding febrile seizures
of childhood.
* Febrile seizures is a type of convulsion associated with a significant rise in body temperature.
They most commonly occur in children.
21. Subject are immunocompromised as evidenced by any of the following:
(a) Human immunodeficiency virus infection, with either a current acquired immune deficiency
syndrome-defining condition (eg, Kaposi’s sarcoma, Pneumocystis carinii pneumonia) or a
CD4 + T lymphocyte count <200/mm3 at the time of study entry
(b) Metastatic or hematological malignancy requiring chemotherapeutic interventions within 6
weeks prior to randomization
(c) Immunosuppressive therapy, including maintenance corticosteroid therapy (>40 mg/day
equivalent prednisolone).
22. Subject are participating in any other clinical study that involves the administration of an
investigational medication at the time of presentation, during the course of the study, or have
received treatment with an investigational medication in the 30 days prior to study enrollment.
23. Subject are in a situation or have a condition that, in the investigator’s opinion, may interfere
with optimal participation in the study.
24. Subject are unlikely to comply with protocol, eg, uncooperative attitude, inability to return for
follow-up visits, and unlikely to complete the study.
25. Subject have previously been treated with CAZ-AVI.
26. Subject have known inflammatory bowel disease (ulcerative colitis or Crohn’s disease).
27. Subject have known C. difficile-associated diarrhea.
28. Subject had been previously enrolled in this study.
29. Subject are pregnant or breastfeeding. A serum β- hCG pregnancy test must be sent for
women of childbearing potential at the screening visit. If the results of the serum β-hCG
cannot be obtained prior to dosing of IP, a patient may be enrolled on the basis of a
negative urine pregnancy test, though serum β-hCG must still be obtained. If either test is
positive, the patient must be excluded. Since urine and serum tests may miss a pregnancy
in the first days after conception, relevant sexual history, including methods of
contraception should be considered. Any patient whose sexual history suggests the
possibility of early pregnancy must be excluded.
The Estimated Number of Participants
-
Taiwan
60 participants
-
Global
1106 participants
