AppendicitisPhase 4NCT00230971
Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection (cIAI)
A Phase 4 study testing tigecycline and ceftriaxone plus metronidazole in people with Appendicitis and Cholecystitis, run by Wyeth is now a wholly owned subsidiary of Pfizer at 68 sites in 19 countries.
Trial summary
This is a study of the safety and efficacy of tigecycline to ceftriaxone sodium plus metronidazole in hospitalized subjects with cIAI. Subjects will be followed for efficacy through the test-of-cure assessment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Appendicitis, Cholecystitis, Diverticulitis
- What is being tested?
- tigecycline and ceftriaxone plus metronidazole
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 473 participants
- Where
- 68 sitesin 19 countries
- Study dates
- Oct 2005to Sep 2008
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of complicated intra-abdominal infection that requires surgery within 24 hours.
- Fever plus other symptoms such as nausea, vomiting, abdominal pain.
Who cannot join
- Cancer
- Medicines that suppress the immune system
- Dialysis
Trial locations and contacts
68 sites in 19 countries.
68 sites in 19 countries
Germany8 sites
Study site
Bochum, 44791
Study site
Frankfurt, 60590
Study site
Freiburg im Breisgau, 79106
Study site
Heidelberg, 69120
Study site
Leipzig, 04129
Study site
Lübeck, 23538
Study site
Münster, 48149
Study site
Tübingen, 72056
Italy6 sites
Study site
Brescia, 25123
Study site
Genova, 16132
Study site
Pavia, 27100
Study site
Rome, 00168
Study site
Udine, 33100
Study site
Vicenza, 36100
India5 sites
Study site
Bhopal, 462 038
Study site
Hyderabad, Telangana, 500 082
Study site
Lucknow, 226 014
Study site
Mumbai, 400071
Study site
New Delhi, 110060
South Africa5 sites
Study site
Bellville, 7530
Study site
Kuilsriver, 7580
Study site
Parow, 7505
Study site
Pietermaritzburg, 3201
Study site
Pretoria, 001
Spain5 sites
Study site
Barcelona, 08003
Study site
Bilbao, 48903
Study site
Madrid, 28040
Study site
Madrid, 28905
Study site
Murcia, 30120
Taiwan5 sites
Study site
Changhua, 500
Study site
Taichung, 404
Study site
Tainan
Study site
Taipei, 100
Study site
Taoyuan, 333
France4 sites
Study site
Marseille, 13 009
Study site
Nîmes, 30 029
Study site
Pierre-Bénite, 69495
Study site
Saint-Denis, 93205
Portugal4 sites
Study site
Almada, 2801-951
Study site
Coimbra, 3000-075
Study site
Porto, 4099-100
Study site
Porto, 4200-319
Switzerland4 sites
Study site
Bern, 3010
Study site
Geneva, 1211
Study site
Lugano, 6900
Study site
Zurich, 8091
Australia3 sites
Study site
Cairns, QLD 4870
Study site
Nambour, Queensland, 4560
Study site
Parkville, VIC 3050
Finland3 sites
Study site
Lahti, 15850
Study site
Seinäjoki, 60220
Study site
Tampere, 33101
Greece3 sites
Study site
Athens, 11527
Study site
Athens, 12462
Study site
Thessaloniki, 54623
Philippines3 sites
Study site
Manila, 1000
Study site
Quezon City, 1100
Study site
Quezon City, 1105
United Kingdom3 sites
Study site
Birmingham, B9 5SS
Study site
Stockport, Cheshire, SK2 7JE
Study site
Wigan, WN1 2NN
Turkey (Türkiye)2 sites
Study site
Ankara, 06100
Study site
Istanbul, 34718
About this study
Official title: A Multicenter, Open-Label, Randomized Comparative Study of Tigecycline vs Ceftriaxone Sodium Plus Metronidazole for the Treatment of Hospitalized Subjects With Complicated Intra-abdominal Infection
This is a study of the safety and efficacy of tigecycline to ceftriaxone sodium plus metronidazole in hospitalized subjects with cIAI. Subjects will be followed for efficacy through the test-of-cure assessment. Safety evaluations will occur through the treatment and post-treatment periods and continue through resolution or stability of the adverse event(s).
- Conditions
- Appendicitis, Cholecystitis, Diverticulitis, Intra-Abdominal Abscess, Intra-Abdominal Infection, Peritonitis
- Being tested
- tigecycline, ceftriaxone plus metronidazole
- Keywords
- Intra-Abdominal Infections, Abscess
- Medical subject headings
- Appendicitis, Cholecystitis, Diverticulitis, Abdominal Abscess, Intraabdominal Infections, Peritonitis, Abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tigecyclineDrug
every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)
ceftriaxone plus metronidazoleDrug
Ceftriaxone sodium 2 g once daily intravenously plus metronidazole 1 g to 2 g daily given in divided doses intravenously. Test article should be administered for a minimum of 4 days and up to 14 days at the discretion of the investigator.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Not described Receives: Drug: tigecycline |
| B | Active comparator | Not described Receives: Drug: ceftriaxone plus metronidazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Clinically Evaluable (CE) Patients With Clinical Response of Cure at the Test-of-Cure (TOC) Visit
CE population were those who completed TOC assessment of cure or failure (but not indeterminate) or, in case of premature discontinuation due to lack of efficacy, had completed end of treatment assessment such that assessment of clinical response could be made. Clinical response was assigned by investigator per protocol-specified guidelines and defined as: test article and initial intervention (operative and/or radiologically controlled drainage procedure) resolved the intra-abdominal infection. TOC performed 10-28 days after last dose of study drug.
Measured: up to 6 weeks
Secondary outcomes (3)
Number of Microbiologically Evaluable (ME) Patients With a Clinical Response of Cure at Test-of-Cure (TOC) Visit
ME population were subjects who were clinically evaluable and had baseline culture with at least 1 identified isolate that was susceptible to study drug and comparator. The clinical response was assigned by the investigator according to the protocol-specified guidelines. A clinical response of cure was defined as: the test article and the initial intervention (operative and/or radiologically controlled drainage procedure) resolved the intra-abdominal infection.
Measured: up to 6 weeks
Number of Microbiologically Evaluable (ME) Patients by Microbiological Response at Test-of-Cure (TOC) Visit
Microbiological response was assessed at patient level was the combined responses for all baseline isolates identified in intra-abdominal and blood cultures. Eradication=baseline isolate not recovered from primary infection site/blood; Presumed Eradication=No sample for culture, clinical response was cure; Persistence=baseline isolate recovered from primary infection site/blood; Presumed Persistence=No sample available for culture, clinical response was failure; Superinfection=culture from primary infection site with new isolate not identified at baseline, clinical response was failure.
Measured: up to 6 weeks
Number of Days of Inpatient Healthcare Resource Utilization on or Before Test-of-Cure
Healthcare resource utilization assessment included days of overall inpatient hospitalization, days of primary inpatient hospitalization, days of Intensive Care Unit (ICU) treatment and days of non-ICU inpatient hospitalization
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2005 (estimated)
- Study startOct 2005
- Primary completionSep 2008
- Study completionSep 2008
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 AppendicitisStudies of the same condition, open and under way.
- 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
- 473 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of PfizerTrial Manager, Principal investigator, For Australia, China, Hong Kong, medinfo@wyeth.comTrial Manager, Principal investigator, For Taiwan, medinfo@wyeth.comTrial Manager, Principal investigator, For Denmark, Finland, MedInfoNord@wyeth.comTrial Manager, Principal investigator, For Germany, MedinfoDEU@wyeth.comTrial Manager, Principal investigator, For South Africa, ZAFinfo@wyeth.comTrial Manager, Principal investigator, For Italy, Greece, decresg@wyeth.comTrial Manager, Principal investigator, For UK, ukmedinfo@wyeth.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00230971
- Sponsor's protocol ID
- 3074A1-315
- Status last verified
- Feb 2013
- First submitted
- 30 Sep 2005
- Last updated
- 25 Feb 2013
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Qvist N, Warren B, Leister-Tebbe H, Zito ET, Pedersen R, McGovern PC, Babinchak T. Efficacy of tigecycline versus ceftriaxone plus metronidazole for the treatment of complicated intra-abdominal infections: results from a randomized, controlled trial. Surg Infect (Larchmt). 2012 Apr;13(2):102-9. doi: 10.1089/sur.2011.048. Epub 2012 Mar 22.
PubMed 22439781
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Randomized Comparative Study of Tigecycline vs Ceftriaxone Sodium Plus Metronidazole for the Treatment of Hospitalized Subjects With Complicated Intra-abdominal Infection
- ClinicalTrials.gov ID
- NCT00230971
- Acronym / sponsor ID
- 3074A1-315
- Conditions
- Appendicitis, Cholecystitis, Diverticulitis, Intra-Abdominal Abscess, Intra-Abdominal Infection, Peritonitis
- Keywords
- Intra-Abdominal Infections, Abscess
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 473 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 3 Oct 2005 (estimated)
- Results
- Posted 26 Apr 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study of the safety and efficacy of tigecycline to ceftriaxone sodium plus metronidazole in hospitalized subjects with cIAI. Subjects will be followed for efficacy through the test-of-cure assessment. Safety evaluations will occur through the treatment and post-treatment periods and continue through resolution or stability of the adverse event(s).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: tigecycline |
| B | Active comparator | Drug: ceftriaxone plus metronidazole |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of complicated intra-abdominal infection that requires surgery within 24 hours.
- Fever plus other symptoms such as nausea, vomiting, abdominal pain.
Key exclusion criteria (3 listed)
- Cancer
- Medicines that suppress the immune system
- Dialysis
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 |
|---|---|---|
| tigecyclineevery 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours) | Drug | A |
| ceftriaxone plus metronidazoleCeftriaxone sodium 2 g once daily intravenously plus metronidazole 1 g to 2 g daily given in divided doses intravenously. Test article should be administered for a minimum of 4 days and up to 14 days at the discretion of the investigator. | Drug | B |
Primary outcome
Number of Clinically Evaluable (CE) Patients With Clinical Response of Cure at the Test-of-Cure (TOC) Visit
Time frame: up to 6 weeks
CE population were those who completed TOC assessment of cure or failure (but not indeterminate) or, in case of premature discontinuation due to lack of efficacy, had completed end of treatment assessment such that assessment of clinical response could be made. Clinical response was assigned by investigator per protocol-specified guidelines and defined as: test article and initial intervention (operative and/or radiologically controlled drainage procedure) resolved the intra-abdominal infection. TOC performed 10-28 days after last dose of study drug.
3 secondary outcomes
Number of Microbiologically Evaluable (ME) Patients With a Clinical Response of Cure at Test-of-Cure (TOC) Visit
Time frame: up to 6 weeks
Number of Microbiologically Evaluable (ME) Patients by Microbiological Response at Test-of-Cure (TOC) Visit
Time frame: up to 6 weeks
Number of Days of Inpatient Healthcare Resource Utilization on or Before Test-of-Cure
Time frame: up to 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22439781Qvist N, Warren B, Leister-Tebbe H, Zito ET, Pedersen R, McGovern PC, Babinchak T. Efficacy of tigecycline versus ceftriaxone plus metronidazole for the treatment of complicated intra-abdominal infections: results from a randomized, controlled trial. Surg Infect (Larchmt). 2012 Apr;13(2):102-9. doi: 10.1089/sur.2011.048. Epub 2012 Mar 22.
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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.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
Trial Manager principal investigator
For Australia, China, Hong Kong, medinfo@wyeth.com
Trial Manager principal investigator
For Taiwan, medinfo@wyeth.com
68 sites in 19 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing tigecycline and ceftriaxone plus metronidazole in people with Appendicitis and Cholecystitis, run by Wyeth is now a wholly owned subsidiary of Pfizer at 68 sites in 19 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 2 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 25 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 68 sites in Germany, Italy, India, South Africa, Spain and 14 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 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?
Yes. Results are posted in the registry (first posted 26 Apr 2010). 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 Clinically Evaluable (CE) Patients With Clinical Response of Cure at the Test-of-Cure (TOC) Visit (time frame: up to 6 weeks). 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 NCT00230971, 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 25 Feb 2013.