Ceftazidime-Avibactam for the Treatment of Infections Due to Ceftazidime Resistant Pathogens

NCT01644643

Last updated date
Study Location
Research Site
Shreveport, Louisiana, , United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Complicated Urinary Tract Infection, Complicated Intra-abdominal Infection
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

- Patient must be ≥18 and ≤90 years of age

- Female patients can participate if they are surgically sterile or completed menopause or females capable of having children and agree not to attempt pregnancy while receiving IV study therapy and for a period of 7 days after

- Patient has a ceftazidime-resistant Gram negative pathogen that was isolated from an appropriate culture within 5 days prior to study entry (ie, within 5 days prior to Screening; the study-qualifying culture), which was determined to be the causative agent of the entry infection

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


- Patient has an APACHE II score >30 (cIAI patients only)


- Patient has an infection due to Gram negative pathogen that is unlikely to respond to
CAZ-AVI treatment (eg, Acinetobacter spp., Stenotrophomonas spp.)


- Patient is receiving hemodialysis or peritoneal dialysis or had a renal transplant
Patient is immunocompromised


- Patient has a rapidly progressive or terminal illness with a high risk of mortality
due to any cause, including acute hepatic failure, respiratory failure or severe
septic shock such that they are unlikely to survive the 4- to 5-week study period.

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Complicated Urinary Tract Infection, Complicated Intra-abdominal InfectionCeftazidime-Avibactam for the Treatment of Infections Due to Ceftazidime Resistant Pathogens NCT01644643
  1. Shreveport, Louisiana
  2. Lima, Ohio
  3. El Talar,
  4. La Plata,
  5. Pazardzhik,
  6. Pleven,
  7. Ruse,
  8. Sofia,
  9. Varna,
  10. Veliko Turnovo,
  11. Slavonski Brod,
  12. Zagreb,
  13. Praha 5,
  14. Tours,
  15. Nazareth,
  16. Petach Tikva,
  17. Ramat-Gan,
  18. Tel Aviv,
  19. Seoul,
  20. Guadalajara,
  21. Mexico, Distrito Federal,
  22. Cusco,
  23. Surco,
  24. Manila,
  25. Szczecin,
  26. Bucharest,
  27. Bucuresti,
  28. Irkutsk,
  29. Krasnodar,
  30. Novosibirsk,
  31. Penza,
  32. Saint-Petersburg,
  33. St. Petersburg,
  34. St.-Petersburg,,
  35. Yaroslavl,
  36. Johannesburg,
  37. Barcelona,
  38. Madrid,
  39. Ankara,
  40. Antalya,
  41. Diyarbakir,
  42. Istanbul,
  43. Dnipropetrovsk,
  44. Kharkiv,
  45. Kyiv,
  46. Zaporizhzhya,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Ceftazidime-Avibactam for the Treatment of Infections Due to Ceftazidime Resistant Pathogens
Official Title  ICMJE An Open-Label, Randomized, Multicenter, Phase III Study of Ceftazidime Avibactam (CAZ-AVI, Formerly CAZ104) and Best Available Therapy for the Treatment of Infections Due to Ceftazidime Resistant Gram Negative Pathogens
Brief Summary To Evaluate the Effects of Ceftazidime-Avibactam and Best Available Therapy in patients with complicated urinary tract infections and complicated intra-abdominal infections.
Detailed Description An Open-Label, Randomized, Multicenter, Phase III Study of Ceftazidime Avibactam (CAZ-AVI, formerly CAZ104) and Best Available Therapy for the Treatment of Infections Due to Ceftazidime Resistant Gram Negative Pathogens
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Complicated Urinary Tract Infection
  • Complicated Intra-abdominal Infection
Intervention  ICMJE
  • Drug: Ceftazidime - Avibactam ( CAZ-AVI)
    Ceftazidime 2000 mg and 500 mg of avibactam Patients randomized to receive CAZ-AVI will receive an infusion of CAZ-AVI (2000 mg ceftazidime and 500 mg avibactam) every 8 hours administered by intravenous (IV) infusion in a volume of 100 mL at a constant rate over 120 minutes
  • Drug: Best Available Therapy
    Patients randomized to receive Best Available Therapy will receive the best available standard of care (SOC) anti-infective therapy for their infection administered in accord with approved local label recommendation
  • Drug: Metronidazole
    Anti-infective, 500 mg (cIAI only) Patients randomized to receive CAZ-AVI for cIAI will also receive metronidazole (500 mg) administered by IV infusion in a volume of 100 mL at a constant rate over 60 minutes immediately following the CAZ-AVI infusion
    Other Name: Flagyl
Study Arms  ICMJE
  • Experimental: Ceftazidime - Avibactam ( CAZ-AVI)
    IV treatment
    Interventions:
    • Drug: Ceftazidime - Avibactam ( CAZ-AVI)
    • Drug: Metronidazole
  • Active Comparator: Best Available Therapy
    IV treatment
    Intervention: Drug: Best Available Therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 1, 2014)
345
Original Estimated Enrollment  ICMJE
 (submitted: July 18, 2012)
400
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient must be ?18 and ?90 years of age
  • Female patients can participate if they are surgically sterile or completed menopause or females capable of having children and agree not to attempt pregnancy while receiving IV study therapy and for a period of 7 days after
  • Patient has a ceftazidime-resistant Gram negative pathogen that was isolated from an appropriate culture within 5 days prior to study entry (ie, within 5 days prior to Screening; the study-qualifying culture), which was determined to be the causative agent of the entry infection

Exclusion Criteria:

  • Patient has an APACHE II score >30 (cIAI patients only)
  • Patient has an infection due to Gram negative pathogen that is unlikely to respond to CAZ-AVI treatment (eg, Acinetobacter spp., Stenotrophomonas spp.)
  • Patient is receiving hemodialysis or peritoneal dialysis or had a renal transplant Patient is immunocompromised
  • Patient has a rapidly progressive or terminal illness with a high risk of mortality due to any cause, including acute hepatic failure, respiratory failure or severe septic shock such that they are unlikely to survive the 4- to 5-week study period.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Bulgaria,   Croatia,   Czechia,   France,   Israel,   Korea, Republic of,   Mexico,   Peru,   Philippines,   Poland,   Romania,   Russian Federation,   South Africa,   Spain,   Turkey,   Ukraine,   United States
Removed Location Countries Australia,   Belgium,   Brazil,   Chile,   China,   Czech Republic,   Denmark,   Finland,   Germany,   Greece,   Hungary,   India,   Italy,   Japan,   Puerto Rico,   Taiwan,   United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT01644643
Other Study ID Numbers  ICMJE D4280C00006
2012-000726-21
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Forest Laboratories
Investigators  ICMJE
Study Director:Paul Newell, MBBS, MRCPAstraZeneca
PRS Account Pfizer
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP