Prospective Multicenter Doubleblind Randomized Study of NXL104/Ceftazidime + Metronidazole vs. Meropenem in Treatment of Complicated Intra-abdominal Infections

NCT00752219

Last updated date
Study Location
University of Southern California
Los Angeles, California, 90033, 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 Intra-abdominal Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- complicated intra-abdominal infections

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


- infections limited to hollow viscus


- ischemic bowel disease without perforation


- acute suppurative cholangitis


- acute necrotizing pancreatitis


- pts to undergo stated abdominal repair, open abdomen technique or marsupialization


- Apache II >25

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Complicated Intra-abdominal InfectionsProspective Multicenter Doubleblind Randomized Study of NXL104/Ceftazidime + Metronidazole vs. Meropenem in Treatment of Complicated Intra-abdominal Infections NCT00752219
  1. Los Angeles, California
  2. Los Angeles, California
  3. Palm Springs, California
  4. Detroit, Michigan
  5. Butte, Montana
  6. Somers Point, New Jersey
  7. Akron, Ohio
  8. Columbus, Ohio
  9. Toledo, Ohio
  10. Plovdiv,
  11. Rousse,
  12. Sofia,
  13. Sofia,
  14. Sofia,
  15. Marseille,
  16. Nice,
  17. Nimes,
  18. Ahmedabad,
  19. Bangalore,
  20. Bangalore,
  21. Bangalore,
  22. Cochin,
  23. Indore,
  24. Jaipur,
  25. Lucknow,
  26. Beirut,
  27. Beirut,
  28. Beirut,
  29. Saida,
  30. Saida,
  31. Katowice,
  32. Nowe Ogrody,
  33. Warszawa,
  34. Warszawa,
  35. Wroclaw,
  36. Bucharest,
  37. Bucharest,
  38. Bucharest,
  39. Bucharest,
  40. Moscow,
  41. Moscow,
  42. Moscow,
  43. Moscow,
  44. Smolensk,
  45. Vladikavkas,
ALL GENDERS
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years
MULTIPLE SITES
Complicated Intra-abdominal InfectionsEvaluation of Safety,Pharmacokinetics and Efficacy of CAZ-AVI With Metronidazole in Children Aged 3 Months to 18 Years Old With Complicated Intra-abdominal Infections (cIAIs). NCT02475733
  1. Orange, California
  2. San Diego, California
  3. Toledo, Ohio
  4. Tulsa, Oklahoma
  5. Kolin III,
  6. Kolin III,
  7. Most,
  8. Most,
  9. Ostrava - Poruba,
  10. Ostrava - Poruba,
  11. Praha 4 - Krc,
  12. Praha 4 - Krc,
  13. Strakonice,
  14. Strakonice,
  15. Athens, Attica
  16. Thessaloniki, Macedonia
  17. Budapest,
  18. Nagykanizsa,
  19. Pecs,
  20. Szeged,
  21. Szekszard,
  22. Lublin,
  23. Iasi,
  24. Smolensk, Smolensk Region
  25. Badalona, Barcelona
  26. Esplugues de LLobregat, Barcelona
  27. Madrid,
  28. Madrid,
  29. Valencia,
  30. Kaohsiung,
  31. Taichung,
  32. Taipei,
  33. Adana,
  34. Eskisehir,
  35. Manisa,
ALL GENDERS
3 Months+
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MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Prospective Multicenter Doubleblind Randomized Study of NXL104/Ceftazidime + Metronidazole vs. Meropenem in Treatment of Complicated Intra-abdominal Infections
Official Title  ICMJE A Prospective, Multicenter, Double-blind, Randomized, Comparative Study to Estimate the Safety, Tolerability and Efficacy of NXL104/Ceftazidime Plus Metronidazole vs. Meropenem in the Treatment of Complicated Intra-abdominal Infections in Hospitalized Adults
Brief Summary The purpose of this study is to determine whether NXL104 plus ceftazidime is effective in the treatment of complicated intra-abdominal infections as compared to a comparator group.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Complicated Intra-abdominal Infections
Intervention  ICMJE
  • Drug: ceftazidime/NXL104 + metronidazole
    IV TID
  • Drug: meropenem
    IV TID
    Other Name: merrem
Study Arms  ICMJE
  • Experimental: NXL104/CAZ/MTZ
    NXL104/ceftazidime + metronidazole
    Intervention: Drug: ceftazidime/NXL104 + metronidazole
  • Active Comparator: Meropenem
    Intervention: Drug: meropenem
Publications * Nichols WW, Stone GG, Newell P, Broadhurst H, Wardman A, MacPherson M, Yates K, Riccobene T, Critchley IA, Das S. Ceftazidime-Avibactam Susceptibility Breakpoints against Enterobacteriaceae and Pseudomonas aeruginosa. Antimicrob Agents Chemother. 2018 Oct 24;62(11). pii: e02590-17. doi: 10.1128/AAC.02590-17. Print 2018 Nov.

*   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: June 29, 2018)
204
Original Estimated Enrollment  ICMJE
 (submitted: September 11, 2008)
200
Actual Study Completion Date  ICMJE December 31, 2009
Actual Primary Completion Date November 30, 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • complicated intra-abdominal infections

Exclusion Criteria:

  • infections limited to hollow viscus
  • ischemic bowel disease without perforation
  • acute suppurative cholangitis
  • acute necrotizing pancreatitis
  • pts to undergo stated abdominal repair, open abdomen technique or marsupialization
  • Apache II >25
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 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 Bulgaria,   France,   India,   Lebanon,   Poland,   Romania,   Russian Federation,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00752219
Other Study ID Numbers  ICMJE NXL-104/2002
C3591014 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date June 2018

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