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Determine the PK and Safety and Tolerability of ATM-AVI for the Treatment of cIAIs in Hospitalized Adults (REJUVENATE)

Last updated on May 10, 2018

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Study Location
Nouveau CHU Amiens Picardie
AMIENS Cedex, , 80054 France
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
cIAIs Complicated Intra-Abdominal Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-90 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Provision of informed consent

2. Male or female from 18 to 90 years

3. Female patients are authorized to participate in this clinical study if criteria
concerning pregnancy avoidance stated in the protocol are met

4. Diagnosis of cIAI

EITHER:

Intra-operative/postoperative enrolment with visual confirmation of cIAI. OR
Preoperative enrollment with evidence of systemic inflammatory response, physical and
radiological findings consistent with cIAI; confirmation of cIAI at time of surgery
within 24 hours of study entry

5. Patients who failed prior antibacterial treatment for their current cIAI can be
enrolled but must:

- Have a known or suspected pathogen causing cIAI that is resistant to the prior
therapy

- Require surgical intervention.

6. Patient must have or will have a surgical intervention within 24 hours (before or
after) the administration of the first dose of study drug

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

1. Involvement in the planning and/or conduct of the study

2. Patient has been previously enrolled in this study, previously treated with ATM-AVI or
previously participated in an investigational study containing AVI

3. Patient has participated or intends to participate in any other clinical study that
involves the administration of a study drug during the course of the study, or during
the 30 days prior to study start.

4. History of serious allergy, hypersensitivity (eg, anaphylaxis), or any serious
reaction to aztreonam, carbapenem,monobactam or other ?-lactam antibiotics, avibactam,
nitroimidazoles or metronidazole, or any of the excipients of the study drugs

5. Diagnosis of abdominal wall abscess; small bowel obstruction or ischemic bowel disease
without perforation; traumatic bowel perforation with surgery within 12 hours of
diagnosis; perforation of gastroduodenal ulcer with surgery within 24 hours of
diagnosis primary etiology is not likely to be infectious

6. Simple cholecystitis, gangrenous cholecystitis without rupture, simple appendicitis,
acute suppurative cholangitis, infected necrotizing pancreatitis, pancreatic abscess
or ischaemic/necrotic intestine without perforation

7. Staged abdominal repair (STAR), open abdomen technique or where infection source
control is not likely to be achieved; unlikely to solely respond to antimicrobial
therapy

8. Infection due to a pathogen that is unlikely to respond to ATM-AVI plus metronidazole

9. Rapidly progressive or terminal illness

10. Systemic antibacterial agents received within the 72- hour period prior to study
entry, unless:

1. A new infection and no more than 24 hours of prior antibiotic treatment received
within the 72 hour period prior to study entry or

2. Patient is considered to have failed the previous treatment

11. Concurrent infection that may interfere with the evaluation of clinical cure for the
study therapy

12. requirement for effective concomitant systemic antibacterials or antifungals

13. Creatinine clearance ?30 ml/min or requirement for renal replacement therapy

14. Acute hepatitis in the prior 6 months, chronic hepatitis, cirrhosis, acute hepatic
failure, or acute decompensation of chronic hepatic failure

15. Hepatic disease as indicated by AST or ALT >3 × ULN. Patients with AST and/or ALT >3 ×
ULN and and documented by the investigator as being directly related to cIAI.

16. Patient has a total bilirubin >3 × ULN, unless isolated hyperbilirubinemia is directly
related to cIAI or due to known Gilbert's disease

17. ALP >3 × ULN. Patients with values >3 × ULN and directly related to the infectious process being treated.

18. Immunocompromising illness

19. Active Clostridium difficile associated diarrhoea

20. Any other condition that may confound the results of the study or pose additional
risks

21. Do not resuscitate order

22. Absolute neutrophil count

23. Hematocrit

24. Platelet count

25. Currently receiving probenecid.

26. Pregnant or breastfeeding or if of child bearing potential, not using a medically
accepted effective method of birth control.

27. Unlikely to comply with protocol,

28. Currently receiving anti-convulsant therapy to prevent recurrence of a past history of
seizures.

29. Prior liver, pancreas or small-bowel transplant.

NCT02655419
Pfizer
Completed
Determine the PK and Safety and Tolerability of ATM-AVI for the Treatment of cIAIs in Hospitalized Adults (REJUVENATE)

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Determine the PK and Safety and Tolerability of ATM-AVI for the Treatment of cIAIs in Hospitalized Adults (REJUVENATE)
A Phase Iia Prospective, Open-label, Multicenter Study To Determine The Pharmacokinetics (pk) And Safety And Tolerability Of Aztreonam-avibactam (Atm-avi) For The Treatment Of Complicated Intra-abdominal Infections (Ciais) In Hospitalized Adults
Determine the PK and safety and tolerability of aztreonam-avibactam (ATM-AVI) in the treatment of hospitalized adults with cIAI
A Phase IIa prospective, open-label, multicenter study to determine the pharmacokinetics (PK) and safety and tolerability of aztreonam-avibactam (ATM-AVI) for the treatment of complicated Intra-Abdominal Infections (cIAIs) in hospitalized adults.
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Complicated Intra-Abdominal Infections, cIAIs
  • Drug: ATM-AVI

    Cohort 1:

    (Creatinine clearance > 50 mL/min)6500mg ATM/1777mg AVI on day 1 followed by total daily dose of 6000mg ATM/1640mg AVI

    Cohorts 2 and 3:

    (Creatinine clearance > 50 mL/min) As above, or: 6500 mg ATM/2167 mg on Day 1 followed by a total daily dose of 6000 mg ATM/2000 m AVI

    (Creatinine clearance 31 - 50 mL/min) 4250 mg ATM/1162 mg AVI on Day 1 followed by total daily dose 3000 mg ATM/820 mg AVI, or:

    4250 mg ATM/1417 mg AVI on Day 1 followed by total daily dose 3000 mg ATM/1000 mg AVI

  • Drug: Metronidazole
    Metronidazole 500mg infused over 1 hour every 8 hours
Experimental: ATM-AVI + Metronidazole
Aztreonam-avibactam + metronidazole
Interventions:
  • Drug: ATM-AVI
  • Drug: Metronidazole
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
October 26, 2017
October 26, 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Provision of informed consent
  2. Male or female from 18 to 90 years
  3. Female patients are authorized to participate in this clinical study if criteria concerning pregnancy avoidance stated in the protocol are met
  4. Diagnosis of cIAI

    EITHER:

    Intra-operative/postoperative enrolment with visual confirmation of cIAI. OR Preoperative enrollment with evidence of systemic inflammatory response, physical and radiological findings consistent with cIAI; confirmation of cIAI at time of surgery within 24 hours of study entry

  5. Patients who failed prior antibacterial treatment for their current cIAI can be enrolled but must:

    • Have a known or suspected pathogen causing cIAI that is resistant to the prior therapy
    • Require surgical intervention.
  6. Patient must have or will have a surgical intervention within 24 hours (before or after) the administration of the first dose of study drug

Exclusion criteria:

  1. Involvement in the planning and/or conduct of the study
  2. Patient has been previously enrolled in this study, previously treated with ATM-AVI or previously participated in an investigational study containing AVI
  3. Patient has participated or intends to participate in any other clinical study that involves the administration of a study drug during the course of the study, or during the 30 days prior to study start.
  4. History of serious allergy, hypersensitivity (eg, anaphylaxis), or any serious reaction to aztreonam, carbapenem,monobactam or other ?-lactam antibiotics, avibactam, nitroimidazoles or metronidazole, or any of the excipients of the study drugs
  5. Diagnosis of abdominal wall abscess; small bowel obstruction or ischemic bowel disease without perforation; traumatic bowel perforation with surgery within 12 hours of diagnosis; perforation of gastroduodenal ulcer with surgery within 24 hours of diagnosis primary etiology is not likely to be infectious
  6. Simple cholecystitis, gangrenous cholecystitis without rupture, simple appendicitis, acute suppurative cholangitis, infected necrotizing pancreatitis, pancreatic abscess or ischaemic/necrotic intestine without perforation
  7. Staged abdominal repair (STAR), open abdomen technique or where infection source control is not likely to be achieved; unlikely to solely respond to antimicrobial therapy
  8. Infection due to a pathogen that is unlikely to respond to ATM-AVI plus metronidazole
  9. Rapidly progressive or terminal illness
  10. Systemic antibacterial agents received within the 72- hour period prior to study entry, unless:

    1. A new infection and no more than 24 hours of prior antibiotic treatment received within the 72 hour period prior to study entry or
    2. Patient is considered to have failed the previous treatment
  11. Concurrent infection that may interfere with the evaluation of clinical cure for the study therapy
  12. requirement for effective concomitant systemic antibacterials or antifungals
  13. Creatinine clearance ?30 ml/min or requirement for renal replacement therapy
  14. Acute hepatitis in the prior 6 months, chronic hepatitis, cirrhosis, acute hepatic failure, or acute decompensation of chronic hepatic failure
  15. Hepatic disease as indicated by AST or ALT >3 × ULN. Patients with AST and/or ALT >3 × ULN and < 5 × ULN are eligible if acute, not accompanied by a total bilirubin ? 2xULN and documented by the investigator as being directly related to cIAI.
  16. Patient has a total bilirubin >3 × ULN, unless isolated hyperbilirubinemia is directly related to cIAI or due to known Gilbert's disease
  17. ALP >3 × ULN. Patients with values >3 × ULN and <5 x ULN are eligible if acute and directly related to the infectious process being treated.
  18. Immunocompromising illness
  19. Active Clostridium difficile associated diarrhoea
  20. Any other condition that may confound the results of the study or pose additional risks
  21. Do not resuscitate order
  22. Absolute neutrophil count <1000/?L
  23. Hematocrit <25% or hemoglobin <8 gm/dL.
  24. Platelet count <75,000/?L.
  25. Currently receiving probenecid.
  26. Pregnant or breastfeeding or if of child bearing potential, not using a medically accepted effective method of birth control.
  27. Unlikely to comply with protocol,
  28. Currently receiving anti-convulsant therapy to prevent recurrence of a past history of seizures.
  29. Prior liver, pancreas or small-bowel transplant.
Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France,   Germany,   Spain
 
 
NCT02655419
D4910C00009
C3601001 ( Other Identifier: Alias Study Number )
2015-002726-39 ( EudraCT Number )
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Plan to Share IPD: Yes
URL: http://
Pfizer
Pfizer
Innovative Medicines Initiative (IMI) COMBACTE-CARE
Study Director: Pfizer CT.gov Call Center Pfizer
Principal Investigator: Oliver Cornely Clinical Trials Centre Cologne
Pfizer
November 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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