InfectionPhase 4NCT00360607
A Comparative Phase IV Study Evaluating Efficacy & Safety Of Magnex(Cefoperazone-Sulbactam) In Intraabdominal Infections
A Phase 4 study testing Magnex (Sulbactam Sodium/Cefoperazone Sodium 1:1) Pfizer Ltd., Fortum (Ceftazidime for injection USP) Glaxo Smith Kline Pharmaceuticals Limited and Metrogyl (Metronidazole Injection IP) J.B.Chemicals & Pharmaceuticals Ltd. in people with Infection, run by Pfizer at 20 sites in India.
Trial summary
Intra-abdominal infections are often polymicrobial, and include aerobic as well as anaerobic bacteria. Antibiotics used in intra-abdominal infections should aim to cover organisms such as Enterobacteriaceae and Bacteroides fragilis, which are the commonest organisms known to cause such infections. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Infection
- What is being tested?
- Magnex (Sulbactam Sodium/Cefoperazone Sodium 1:1) Pfizer Ltd., Fortum (Ceftazidime for injection USP) Glaxo Smith Kline Pharmaceuticals Limited and Metrogyl (Metronidazole Injection IP) J.B.Chemicals & Pharmaceuticals Ltd.
- Type of treatment
- Injection or infusion
- How many people
- 307 participants
- Where
- 20 sitesIndia
- Study dates
- Jul 2004to Apr 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female subjects aged greater or equal to 12 years
- Intra-abdominal infection documented by laparotomy or laparoscopy or percutaneous aspiration within 24 hours prior to screening
- Presence of at least three of the following five indicators consistent with intra-abdominal infections (Fever, leucocytosis, abdominal symptoms, abdominal signs, radiological evaluation)
- Written informed consent obtained
Who cannot join
- Rapidly progressive illness or critically ill subjects
- Pregnant or lactating women, or women of childbearing potential not using an effective method of contraception.
- Treatment with a presumably effective systemic antimicrobial agent for >24 hours within a 72 hour period prior to study entry unless the subject did not sufficiently respond to the treatment (as judged by the investigator)
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
India20 sites
Pfizer Investigational Site
Ahmedabad, Gujarat, 380 009
Pfizer Investigational Site
Ahmedabad, Gujarat, 380 052
Pfizer Investigational Site
Ahmedabad, Gujarat, 380016
Pfizer Investigational Site
Bangalore, Karnataka, 560 001
Pfizer Investigational Site
Bangalore, 560 054
Pfizer Investigational Site
Bhopal, Madhya Pradesh, 462 038
Pfizer Investigational Site
Chandigarh, 160 012
Pfizer Investigational Site
Coimbatore, 641 014
Pfizer Investigational Site
Hyderabad, 500 068
Pfizer Investigational Site
Hyderabad
Pfizer Investigational Site
Indore, Madhya Pradesh, 452 014
Pfizer Investigational Site
Jaipur, Rajasthan, 302015
Pfizer Investigational Site
Kochi, Kerala, 682 026
Pfizer Investigational Site
Kochi, Kerala, 682304
Pfizer Investigational Site
Lucknow, Uttar Pradesh, 226 014
Pfizer Investigational Site
Lucknow, 226 003
Pfizer Investigational Site
Ludhiana, 141 001
Pfizer Investigational Site
Mumbai, Maharashtra, 400 022
Pfizer Investigational Site
Mumbai, 400 012
Pfizer Investigational Site
Pune, Maharashtra, 411 001
About this study
Official title: A Randomized, Open Label, Multicentre Phase Iv Study To Evaluate The Efficacy And Safety Of Magnex (Cefoperazone-Sulbactam) In Comparison With Ceftazidime Plus Amikacin And Metronidazole In The Treatment Of Intra-Abdominal Infections
Intra-abdominal infections are often polymicrobial, and include aerobic as well as anaerobic bacteria. Antibiotics used in intra-abdominal infections should aim to cover organisms such as Enterobacteriaceae and Bacteroides fragilis, which are the commonest organisms known to cause such infections. Combinations of a third-generation cephalosporin, an aminoglycoside and metronidazole are often used to treat such infections in surgical settings. An alternative to such combinations is the use of a beta lactam - beta lactamase inhibitor combination. Magnex (cefoperazone- sulbactam) is one such combination, which has been shown to be as effective as a standard multidrug regimen such as gentamicin and clindamycin in the management of intra-abdominal infections. The combination of ceftazidime, amikacin and metronidazole has been chosen as a comparator regimen because of its broad coverage of Gram-negative and anaerobic organisms found in such conditions.
- Conditions
- Infection
- Being tested
- Magnex (Sulbactam Sodium/Cefoperazone Sodium 1:1) Pfizer Ltd., Fortum (Ceftazidime for injection USP) Glaxo Smith Kline Pharmaceuticals Limited, Metrogyl (Metronidazole Injection IP) J.B.Chemicals & Pharmaceuticals Ltd., Mikacin (Amikacin Sulphate Injection IP) Aristo Pharmaceuticals Ltd.
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnex (Sulbactam Sodium/Cefoperazone Sodium 1:1) Pfizer Ltd.Drug
Fortum (Ceftazidime for injection USP) Glaxo Smith Kline Pharmaceuticals LimitedDrug
Metrogyl (Metronidazole Injection IP) J.B.Chemicals & Pharmaceuticals Ltd.Drug
Mikacin (Amikacin Sulphate Injection IP) Aristo Pharmaceuticals Ltd.Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of clinical efficacy-evaluable subjects who present with continued resolution at the 30-day follow-up visit.
Adverse events as observed by the investigator or volunteered as responses to unsolicited and non-leading questions.
Vital signs including systolic and diastolic blood pressures, pulse rate and respiratory rate.
Physical examination findings.
Secondary outcomes (6)
The proportion of clinical efficacy
evaluable subjects who are classified as having a clinical outcome of success or improvement at the end of study treatment;
proportion of microbiological efficacy-evaluable subjects who have a successful microbiological outcome
success or presumed success) at the end of study treatment,
Total duration of study treatment
Comparison of pharmaco-economic data (cost effectiveness) for cefoperazone- sulbactam versus the combination of ceftazidime - amikacin - metronidazole.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2006 (estimated)
- Study startJul 2004
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfectionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 307 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00360607
- Sponsor's protocol ID
- A1891002
- Status last verified
- Dec 2008
- First submitted
- 3 Aug 2006
- Last updated
- 2 Dec 2008
- Results posted
- No
Publications
Chandra A, Dhar P, Dharap S, Goel A, Gupta R, Hardikar JV, Kapoor VK, Mathur AK, Modi P, Narwaria M, Ramesh MK, Ramesh H, Sastry RA, Shah S, Virk S, Sudheer OV, Sreevathsa MR, Varshney S, Kochhar P, Somasundaram S, Desai C, Schou M. Cefoperazone-sulbactam for treatment of intra-abdominal infections: results from a randomized, parallel group study in India. Surg Infect (Larchmt). 2008 Jun;9(3):367-76. doi: 10.1089/sur.2007.013.
PubMed 18570578
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Multicentre Phase Iv Study To Evaluate The Efficacy And Safety Of Magnex (Cefoperazone-Sulbactam) In Comparison With Ceftazidime Plus Amikacin And Metronidazole In The Treatment Of Intra-Abdominal Infections
- ClinicalTrials.gov ID
- NCT00360607
- Acronym / sponsor ID
- A1891002
- Conditions
- Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 307 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Study completion
- Apr 2005 (actual)
- First posted
- 4 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Intra-abdominal infections are often polymicrobial, and include aerobic as well as anaerobic bacteria. Antibiotics used in intra-abdominal infections should aim to cover organisms such as Enterobacteriaceae and Bacteroides fragilis, which are the commonest organisms known to cause such infections. Combinations of a third-generation cephalosporin, an aminoglycoside and metronidazole are often used to treat such infections in surgical settings. An alternative to such combinations is the use of a beta lactam - beta lactamase inhibitor combination. Magnex (cefoperazone- sulbactam) is one such combination, which has been shown to be as effective as a standard multidrug regimen such as gentamicin and clindamycin in the management of intra-abdominal infections. The combination of ceftazidime, amikacin and metronidazole has been chosen as a comparator regimen because of its broad coverage of Gram-negative and anaerobic organisms found in such conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female subjects aged greater or equal to 12 years
- Intra-abdominal infection documented by laparotomy or laparoscopy or percutaneous aspiration within 24 hours prior to screening
- Presence of at least three of the following five indicators consistent with intra-abdominal infections (Fever, leucocytosis, abdominal symptoms, abdominal signs, radiological evaluation)
- Written informed consent obtained
Key exclusion criteria (3 listed)
- Rapidly progressive illness or critically ill subjects
- Pregnant or lactating women, or women of childbearing potential not using an effective method of contraception.
- Treatment with a presumably effective systemic antimicrobial agent for >24 hours within a 72 hour period prior to study entry unless the subject did not sufficiently respond to the treatment (as judged by the investigator)
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 |
|---|---|---|
| Magnex (Sulbactam Sodium/Cefoperazone Sodium 1:1) Pfizer Ltd. | Drug | – |
| Fortum (Ceftazidime for injection USP) Glaxo Smith Kline Pharmaceuticals Limited | Drug | – |
| Metrogyl (Metronidazole Injection IP) J.B.Chemicals & Pharmaceuticals Ltd. | Drug | – |
| Mikacin (Amikacin Sulphate Injection IP) Aristo Pharmaceuticals Ltd. | Drug | – |
Primary outcome
Proportion of clinical efficacy-evaluable subjects who present with continued resolution at the 30-day follow-up visit.
Adverse events as observed by the investigator or volunteered as responses to unsolicited and non-leading questions.
Vital signs including systolic and diastolic blood pressures, pulse rate and respiratory rate.
Physical examination findings.
6 secondary outcomes
The proportion of clinical efficacy
evaluable subjects who are classified as having a clinical outcome of success or improvement at the end of study treatment;
proportion of microbiological efficacy-evaluable subjects who have a successful microbiological outcome
success or presumed success) at the end of study treatment,
Total duration of study treatment
Comparison of pharmaco-economic data (cost effectiveness) for cefoperazone- sulbactam versus the combination of ceftazidime - amikacin - metronidazole.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2008.
- Derived from this study: PubMed 18570578Chandra A, Dhar P, Dharap S, Goel A, Gupta R, Hardikar JV, Kapoor VK, Mathur AK, Modi P, Narwaria M, Ramesh MK, Ramesh H, Sastry RA, Shah S, Virk S, Sudheer OV, Sreevathsa MR, Varshney S, Kochhar P, Somasundaram S, Desai C, Schou M. Cefoperazone-sulbactam for treatment of intra-abdominal infections: results from a randomized, parallel group study in India. Surg Infect (Larchmt). 2008 Jun;9(3):367-76. doi: 10.1089/sur.2007.013.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Magnex (Sulbactam Sodium/Cefoperazone Sodium 1:1) Pfizer Ltd., Fortum (Ceftazidime for injection USP) Glaxo Smith Kline Pharmaceuticals Limited and Metrogyl (Metronidazole Injection IP) J.B.Chemicals & Pharmaceuticals Ltd. in people with Infection, run by Pfizer at 20 sites in India.
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 4 inclusion and 3 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 2 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in India. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of clinical efficacy-evaluable subjects who present with continued resolution at the 30-day follow-up visit.. The study lists 4 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 NCT00360607, 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 2 Dec 2008.