Complicated Intra-abdominal InfectionsPhase 2NCT00752219
Prospective Multicenter Doubleblind Randomized Study of NXL104/Ceftazidime + Metronidazole vs. Meropenem in Treatment of Complicated Intra-abdominal Infections
A Phase 2 study testing ceftazidime/NXL104 + metronidazole and meropenem in people with Complicated Intra-abdominal Infections, run by Pfizer at 45 sites in 8 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Complicated Intra-abdominal Infections
- What is being tested?
- ceftazidime/NXL104 + metronidazole and meropenem
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 45 sitesin 8 countries
- Study dates
- 31 Mar 2009to 31 Dec 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- complicated intra-abdominal infections
Who cannot join
- 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
Trial locations and contacts
45 sites in 8 countries.
45 sites in 8 countries
United States9 sites
Summa Health Systems
Akron, Ohio
Mercury Street Medical Group
Butte, Montana
Remington-Daviss Inc
Columbus, Ohio
Henry Ford Health System
Detroit, Michigan
University of Southern California
Los Angeles, California, 90033
Cedars-Sinai Medical Center Dept of Surgery
Los Angeles, California
Michael S. Somero Research Division
Palm Springs, California
South Jersey Infectious Disease
Somers Point, New Jersey
ID Clinical Research Ltd
Toledo, Ohio
India8 sites
Medisurge Hospital Ahmedabad
Ahmedabad
Medisys Clinisearch India Pvt Ltd
Bangalore
MS Ramaiah Memorial Hospital Bangalore
Bangalore
Victoria Hospital Bangalore
Bangalore
Suyash Hospital Indore
Indore
SR Kalla General and Gastro Hospital
Jaipur
Amrita Institute of Medical Sciences, Cochin
Kochi
Lucknow Cancer Institute Lucknow
Lucknow
Russia6 sites
City Clinical Hospital # 13
Moscow
City Clinical Hospital # 1
Moscow
FGU National Medical Surgery
Moscow
Moscow City Clinical Hospital # 31
Moscow
SMO of Clinical Trials
Smolensk
North-Ossetian Medical Academy
Vladikavkas
Bulgaria5 sites
UMHAT Sveti Georgi 3rd Clinical of Surgery
Plovdiv
MHAT Rousse, 2nd Clinical of Surgery
Rousse
CCB Ministry of Interior Clinical of Surgery
Sofia
Multiprofile Hospital for Active Trt Emergency Med
Sofia
UMHAT Queen Joanna-ISUL, Clinical of Surgery
Sofia
Lebanon5 sites
Al-Zahraa university Hospital
Beirut
Makassed General Hospital
Beirut
Rafik Heriri University Hospital
Beirut
Hammound Hospital University Medical Center
Saida
Labib Medical Center
Saida
Poland5 sites
Slaski Uniwersytet Medyczny
Katowice
Pomorskie Centrum Traumatologii
Nowe Ogrody
Katedra i Klinika Chirurgii Ogolnej
Warsaw
Samodzielny Publiczny
Warsaw
Akademicki Szpital Kliniczn
Wroclaw
Romania4 sites
Coltea Clinical Hospital
Bucharest
Floreasca Clinical Emergency Hospital
Bucharest
Fundeni Clinical Institute
Bucharest
University Emergency Hospital Bucharest
Bucharest
France3 sites
Hospital Saint Joseph Marseille
Marseille
Hospital L'Archet II
Nice
CHU Nimes
Nîmes
About this study
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
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.
- Conditions
- Complicated Intra-abdominal Infections
- Being tested
- ceftazidime/NXL104 + metronidazole, meropenem
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ceftazidime/NXL104 + metronidazoleDrug
IV TID
meropenemDrug
Also called merrem
IV TID
| Study group | Role | What they receive |
|---|---|---|
| NXL104/CAZ/MTZ | Experimental | NXL104/ceftazidime + metronidazole Receives: Drug: ceftazidime/NXL104 + metronidazole |
| Meropenem | Active comparator | Not described Receives: Drug: meropenem |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Test of cure visit: 2 weeks post-therapy (Day 28)
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.
Measured: Baseline up to 6 weeks after last dose of study treatment (up to a maximum of 8 weeks)
Secondary outcomes (8)
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.
Measured: End of IV therapy: From Day 5 to Day 14
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.
Measured: Late follow-up visit: 4 to 6 weeks post-therapy (up to 8 weeks)
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.
Measured: Test of cure visit: 2 weeks post-therapy (Day 28)
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.
Measured: End of IV therapy: From Day 5 to Day 14
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)
Measured: Late follow-up visit: 4 to 6 weeks post-therapy (up to 8 weeks)
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.
Measured: Test of cure visit: 2 weeks post-therapy (Day 28)
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.
Measured: End of IV therapy: From Day 5 to Day 14
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.
Measured: Late follow-up visit: 4 to 6 weeks post-therapy (up to 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2008 (estimated)
- Study start31 Mar 2009
- Primary completion30 Nov 2009
- Study completion31 Dec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Complicated Intra-abdominal InfectionsStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00752219
- Sponsor's protocol ID
- NXL-104/2002
- Other IDs
- C3591014
- Status last verified
- Jun 2018
- First submitted
- 11 Sep 2008
- Last updated
- 3 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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):e02590-17. doi: 10.1128/AAC.02590-17. Print 2018 Nov.
PubMed 30061279
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00752219
- Acronym / sponsor ID
- NXL-104/2002
- Conditions
- Complicated Intra-abdominal Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2009 (actual)
- Primary completion
- 30 Nov 2009 (actual)
- Study completion
- 31 Dec 2009 (actual)
- First posted
- 15 Sep 2008 (estimated)
- Results
- Posted 3 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NXL104/CAZ/MTZ | Experimental | Drug: ceftazidime/NXL104 + metronidazoleNXL104/ceftazidime + metronidazole |
| Meropenem | Active comparator | Drug: meropenem |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- complicated intra-abdominal infections
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ceftazidime/NXL104 + metronidazoleIV TID | Drug | NXL104/CAZ/MTZ |
| meropenemAlso: merremIV TID | Drug | Meropenem |
Primary outcome
Number of Participants With Clinical Response at the Test of Cure (TOC) Visit
Time frame: Test of cure visit: 2 weeks post-therapy (Day 28)
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.
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Baseline up to 6 weeks after last dose of study treatment (up to a maximum of 8 weeks)
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.
8 secondary outcomes
Number of Participants With Clinical Response at the End of Intravenous (IV) Therapy
Time frame: End of IV therapy: From Day 5 to Day 14
Number of Participants With Clinical Response at the Late Follow-up Visit
Time frame: Late follow-up visit: 4 to 6 weeks post-therapy (up to 8 weeks)
Number of Participants With Microbiological Response at the Test of Cure Visit
Time frame: Test of cure visit: 2 weeks post-therapy (Day 28)
Number of Participants With Microbiological Response at the End of IV Therapy
Time frame: End of IV therapy: From Day 5 to Day 14
Number of Participants With Microbiological Response at the Late Follow-up Visit
Time frame: Late follow-up visit: 4 to 6 weeks post-therapy (up to 8 weeks)
Number of Participants With Clinical Response in Clinically Evaluable (CE) Participants at the Test of Cure Visit
Time frame: Test of cure visit: 2 weeks post-therapy (Day 28)
Number of Participants With Clinical Response in CE Participants at the End of IV Therapy
Time frame: End of IV therapy: From Day 5 to Day 14
Number of Participants With Clinical Response in CE Participants at the Late Follow-up Visit
Time frame: Late follow-up visit: 4 to 6 weeks post-therapy (up to 8 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30061279Nichols 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):e02590-17. doi: 10.1128/AAC.02590-17. Print 2018 Nov.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
45 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ceftazidime/NXL104 + metronidazole and meropenem in people with Complicated Intra-abdominal Infections, run by Pfizer at 45 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United States, India, Russia, Bulgaria, Lebanon and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Clinical Response at the Test of Cure (TOC) Visit (time frame: Test of cure visit: 2 weeks post-therapy (Day 28)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00752219, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2018.