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

Complicated Intra-abdominal Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00752219
• Other study ID #: NXL-104/2002
• Secondary ID: C3591014
• Status: Completed
• Phase: Phase 2
• Start date: March 31, 2009
• Est. completion date: December 31, 2009

Study information

• Verified date: June 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: December 31, 2009
• Est. primary completion date: November 30, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Complicated Intra-abdominal Infections
• Infection
• Intraabdominal Infections

Intervention

Drug:
• ceftazidime/NXL104 + metronidazole
IV TID
• meropenem
IV TID

Locations

Country	Name	City	State
Bulgaria	UMHAT Sveti Georgi 3rd Clinical of Surgery	Plovdiv
Bulgaria	MHAT Rousse, 2nd Clinical of Surgery	Rousse
Bulgaria	CCB Ministry of Interior Clinical of Surgery	Sofia
Bulgaria	Multiprofile Hospital for Active Trt Emergency Med	Sofia
Bulgaria	UMHAT Queen Joanna-ISUL, Clinical of Surgery	Sofia
France	Hospital Saint Joseph Marseille	Marseille
France	Hospital L'Archet II	Nice
France	CHU Nimes	Nimes
India	Medisurge Hospital Ahmedabad	Ahmedabad
India	Medisys Clinisearch India Pvt Ltd	Bangalore
India	MS Ramaiah Memorial Hospital Bangalore	Bangalore
India	Victoria Hospital Bangalore	Bangalore
India	Amrita Institute of Medical Sciences, Cochin	Cochin
India	Suyash Hospital Indore	Indore
India	SR Kalla General and Gastro Hospital	Jaipur
India	Lucknow Cancer Institute Lucknow	Lucknow
Lebanon	Al-Zahraa university Hospital	Beirut
Lebanon	Makassed General Hospital	Beirut
Lebanon	Rafik Heriri University Hospital	Beirut
Lebanon	Hammound Hospital University Medical Center	Saida
Lebanon	Labib Medical Center	Saida
Poland	Slaski Uniwersytet Medyczny	Katowice
Poland	Pomorskie Centrum Traumatologii	Nowe Ogrody
Poland	Katedra i Klinika Chirurgii Ogolnej	Warszawa
Poland	Samodzielny Publiczny	Warszawa
Poland	Akademicki Szpital Kliniczn	Wroclaw
Romania	Coltea Clinical Hospital	Bucharest
Romania	Floreasca Clinical Emergency Hospital	Bucharest
Romania	Fundeni Clinical Institute	Bucharest
Romania	University Emergency Hospital Bucharest	Bucharest
Russian Federation	City Clinical Hospital # 1	Moscow
Russian Federation	City Clinical Hospital # 13	Moscow
Russian Federation	FGU National Medical Surgery	Moscow
Russian Federation	Moscow City Clinical Hospital # 31	Moscow
Russian Federation	SMO of Clinical Trials	Smolensk
Russian Federation	North-Ossetian Medical Academy	Vladikavkas
United States	Summa Health Systems	Akron	Ohio
United States	Mercury Street Medical Group	Butte	Montana
United States	Remington-Daviss Inc	Columbus	Ohio
United States	Henry Ford Health System	Detroit	Michigan
United States	Cedars-Sinai Medical Center Dept of Surgery	Los Angeles	California
United States	University of Southern California	Los Angeles	California
United States	Michael S. Somero Research Division	Palm Springs	California
United States	South Jersey Infectious Disease	Somers Point	New Jersey
United States	ID Clinical Research Ltd	Toledo	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Bulgaria,  France,  India,  Lebanon,  Poland,  Romania,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Clinical Response at the Test of Cure (TOC) Visit	Clinical response was defined as complete resolution or significant improvement of signs and symptoms of the index infection. No further antimicrobial therapy or surgical or radiological intervention was required. This clinical response was measured in participants who were microbiologically evaluable (ME) at baseline.	Test of cure visit: 2 weeks post-therapy (Day 28)
Primary	Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 6 weeks after last dose of study treatment that were absent before treatment or that worsened relative to pretreatment state.	Baseline up to 6 weeks after last dose of study treatment (up to a maximum of 8 weeks)
Secondary	Number of Participants With Clinical Response at the End of Intravenous (IV) Therapy	Clinical response was defined as complete resolution or significant improvement of signs and symptoms of the index infection. No further antimicrobial therapy or surgical or radiological intervention was required. This clinical response was measured in participants who were ME at baseline.	End of IV therapy: From Day 5 to Day 14
Secondary	Number of Participants With Clinical Response at the Late Follow-up Visit	Clinical response was defined as complete resolution or significant improvement of signs and symptoms of the index infection. No further antimicrobial therapy or surgical or radiological intervention was required. This clinical response was measured in participants who were ME at baseline.	Late follow-up visit: 4 to 6 weeks post-therapy (up to 8 weeks)
Secondary	Number of Participants With Microbiological Response at the Test of Cure Visit	Microbiological response was defined as eradication of pathogen identified (absence of causative pathogens from appropriately obtained specimens at site of infection) or presumptive eradication of pathogens (absence of material to culture in a participant who had responded clinically to treatment). This clinical response was measured in participants who were ME at baseline.	Test of cure visit: 2 weeks post-therapy (Day 28)
Secondary	Number of Participants With Microbiological Response at the End of IV Therapy	Microbiological response was defined as eradication of pathogen identified (absence of causative pathogens from appropriately obtained specimens at site of infection) or presumptive eradication of pathogens (absence of material to culture in a participant who had responded clinically to treatment). This clinical response was measured in participants who were ME at baseline.	End of IV therapy: From Day 5 to Day 14
Secondary	Number of Participants With Microbiological Response at the Late Follow-up Visit	Favorable: eradication (absence of causative pathogens from appropriately obtained specimens at site of infection) or presumptive eradication (absence of material to culture in a patient who had responded clinically to treatment)	Late follow-up visit: 4 to 6 weeks post-therapy (up to 8 weeks)
Secondary	Number of Participants With Clinical Response in Clinically Evaluable (CE) Participants at the Test of Cure Visit	Clinical response was defined as complete resolution or significant improvement of signs and symptoms of the index infection. No further antimicrobial therapy or surgical or radiological intervention was required.	Test of cure visit: 2 weeks post-therapy (Day 28)
Secondary	Number of Participants With Clinical Response in CE Participants at the End of IV Therapy	Clinical response was defined as complete resolution or significant improvement of signs and symptoms of the index infection. No further antimicrobial therapy or surgical or radiological intervention was required.	End of IV therapy: From Day 5 to Day 14
Secondary	Number of Participants With Clinical Response in CE Participants at the Late Follow-up Visit	Clinical response was defined as complete resolution or significant improvement of signs and symptoms of the index infection. No further antimicrobial therapy or surgical or radiological intervention was required.	Late follow-up visit: 4 to 6 weeks post-therapy (up to 8 weeks)