AppendicitisPhase 4NCT00195351

Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection

A Phase 4 study testing tigecycline and ceftriaxone sodium + metronidazole in people with Appendicitis and Cholecystitis, run by Wyeth is now a wholly owned subsidiary of Pfizer at 66 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Appendicitis, Cholecystitis, Cross Infection
What is being tested?: tigecycline and ceftriaxone sodium + metronidazole
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 467 participants
Where: 66 sitesin 6 countries
Study dates: Sep 2005to Feb 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 over 100.4°F (38.0°C) or high white blood cell count plus other symptoms such as nausea, vomiting, abdominal pain.

Who cannot join

Cancer
Medicines that suppress the immune system
Dialysis

Trial locations and contacts

66 sites in 6 countries.

Country

City, postcode or hospital

66 sites in 6 countries

United States46 sites

Study site
Atlanta, Georgia, 30342
Study site
Bismarck, North Dakota, 58501
Study site
Boston, Massachusetts, 02118
Study site
Buffalo, New York, 14215
Study site
Butte, Montana, 59701
Study site
Charlottesville, Virginia, 22906
Study site
Chicago, Illinois, 60612
Study site
Cleveland, Ohio, 44109
Study site
Columbus, Ohio, 43210
Study site
Columbus, Ohio, 43215
Study site
Corsiana, Texas, 75151
Study site
Denver, Colorado, 80204
Study site
Denver, Colorado, 80262
Study site
Detroit, Michigan, 48201
Study site
Fargo, North Dakota, 58122
Study site
Fort Worth, Texas, 76135
Study site
Grand Rapids, Michigan, 49506
Study site
Hartford, Connecticut, 06102
Study site
Honolulu, Hawaii, 96813
Study site
Houston, Texas, 77026
Study site
Houston, Texas, 77030
Study site
Indianapolis, Indiana, 46202
Study site
Indianapolis, Indiana, 46280
Study site
Laconia, New Hampshire, 03246
Study site
Laguna Hills, California, 92653
Study site
Lincoln, Nebraska, 68510
Study site
Los Angeles, California, 90033
Study site
Madison, Wisconsin, 53792
Study site
Miami, Florida, 33136
Study site
Milwaukee, Wisconsin, 53226
Study site
Minneapolis, Minnesota, 55422
Study site
Mobile, Alabama, 36617
Study site
Newark, Delaware, 19718
Study site
Orange, California, 92868
Study site
Palm Springs, California, 92262
Study site
Pittsburgh, Pennsylvania, 15261
Study site
Salt Lake City, Utah, 84102
Study site
San Diego, California, 92134
Study site
Springfield, Massachusetts, 01199
Study site
St Louis, Missouri, 63110
Study site
St Louis, Missouri, 63131
Study site
Toledo, Ohio, 43608
Study site
Torrance, California, 90509
Study site
Washington D.C., District of Columbia, 20037
Study site
West Roxbury, Massachusetts, 02132
Study site
Zanesville, Ohio, 43701

Other trials in United States

Canada11 sites

Study site
Ajax, Ontario, L1S 2J5
Study site
Calgary, Alberta, T2N 2T9
Study site
Chicoutimi, Quebec, G7H 5H6
Study site
Greenfield Park, Quebec, J4V 2H1
Study site
Montreal, Quebec, H2X 3J4
Study site
Oshawa, Ontario, L1H 1B9
Study site
Rimouski, Quebec, G5L 5T1
Study site
Toronto, Ontario, M1E 5E9
Study site
Toronto, Ontario, M5T 2S8
Study site
Trois-Rivières, Quebec, G8Z 3R9
Study site
Victoria, British Columbia, V8T 5G4

Other trials in Canada

Argentina3 sites

Study site
Buenos Aires, C1118AAT
Study site
Buenos Aires, C1425DUH
Study site
Buenos Aires, C1431FWO

Other trials in Argentina

Brazil3 sites

Study site
Curitiba, Paraná, 80810-050
Study site
São Paulo, São Paulo, 01323-010
Study site
São Paulo, São Paulo, 04330-020

Other trials in Brazil

Chile2 sites

Study site
Santiago
Study site
Viña del Mar

Other trials in Chile

Mexico1 site

Study site
Mexico D.F. CP, 03100

Other trials in Mexico

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 phase 3b/4 randomized, open-label, comparative, multicenter study of the safety and efficacy of tigecycline to ceftriaxone sodium plus metronidazole in hospitalized subjects with cIAI (Complicated Intra-Abdominal Infection). Subjects with clinical signs and symptoms of cIAI will be included for enrollment. Subjects will be stratified at randomization for Acute Physiologic and Chronic Health Evaluation scale (APACHE II) score < 10 and > 10. 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, Cross Infection, Diverticulitis, Peritonitis
Being tested: tigecycline, ceftriaxone sodium + metronidazole
Keywords: Complicated intra-abdominal infection, Appendicitis with abscess, Perforated diverticulitis, Purulent peritonitis, Complicated cholecystitis
Medical subject headings: Appendicitis, Cholecystitis, Cross Infection, Diverticulitis, Peritonitis

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 sodium + 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 groups in NCT00195351
Study group	Role	What they receive
A	Active comparator	Not described Receives: Drug: tigecycline
B	Active comparator	Not described Receives: Drug: ceftriaxone sodium + metronidazole

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Clinically Evaluable Patients With Clinical Response of Cure at Test-of-Cure (TOC) Visit.
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: 10-21 days after the last dose of test article

Secondary outcomes (2)

Number of Microbiologically Evaluable Patients With a Clinical Response of Cure at Test-of-Cure (TOC) Visit.
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: 10-21 days after the last dose of test article
Number of Patients by Microbiologic Response at Test-of-Cure (TOC) Visit.
Microbiologic response assessed at patient level was combined microbiologic responses for all baseline isolates identified in intra-abdominal/blood cultures. Eradication=baseline isolate not recovered from primary infection site/blood; Presumed Eradication=no material available for culture but response was cure; Persistence=baseline isolate recovered from primary infection site/blood; Presumed Persistence=no material available for culture but response was failure; Superinfection=culture from primary infection site was positive for new isolate not identified at baseline \& response was failure.
Measured: 10-21 days after the last dose of test article

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2005Feb 2008

First posted19 Sep 2005 (estimated)
Study startSep 2005
Primary completionFeb 2008
Study completionFeb 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: Single group
Masking: None (open label)
Enrolment: 467 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00195351
Sponsor's protocol ID: 3074A1-400
Status last verified: Feb 2013
First submitted: 12 Sep 2005
Last updated: 25 Feb 2013
Results posted: Yes, on ClinicalTrials.gov

Publications

Towfigh S, Pasternak J, Poirier A, Leister H, Babinchak T. A multicentre, open-label, randomized comparative study of tigecycline versus ceftriaxone sodium plus metronidazole for the treatment of hospitalized subjects with complicated intra-abdominal infections. Clin Microbiol Infect. 2010 Aug;16(8):1274-81. doi: 10.1111/j.1469-0691.2010.03122.x.
PubMed 20670293

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Prospective Comparison of Pro-Adrenomedullin, C-Reactive Protein, and Neutrophil-to-Lymphocyte Ratio for Diagnosing Acute Appendicitis
Acute Appendicitis
Active, not recruiting
PAINED: Project Addressing INequities in the Emergency Department
Pain, Appendicitis
Not yet recruiting
Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
Appendicitis, Perforated Appendicitis
Recruiting
Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Acute Appendicitis
RecruitingPhase 3
Laparoscopic Antibiotic Lavage to Prevent Intra-abdominal Abscess Formation in Complicated Appendicitis
Complicated Appendicitis, Intra-Abdominal Abscess

All Appendicitis trials

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: NCT00195351
Acronym / sponsor ID: 3074A1-400
Conditions: Appendicitis, Cholecystitis, Cross Infection, Diverticulitis, Peritonitis
Keywords: Complicated intra-abdominal infection, Appendicitis with abscess, Perforated diverticulitis, Purulent peritonitis, Complicated cholecystitis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 467 participants (actual)
Lead sponsor: Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
Study start: Sep 2005
Primary completion: Feb 2008 (actual)
Study completion: Feb 2008 (actual)
First posted: 19 Sep 2005 (estimated)
Results: Posted 10 Jun 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
A	Active comparator	Drug: tigecycline
B	Active comparator	Drug: ceftriaxone sodium + 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 over 100.4°F (38.0°C) or high white blood cell count 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 sodium + 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 Patients With Clinical Response of Cure at Test-of-Cure (TOC) Visit.
Time frame: 10-21 days after the last dose of test article
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.

2 secondary outcomes

Number of Microbiologically Evaluable Patients With a Clinical Response of Cure at Test-of-Cure (TOC) Visit.
Time frame: 10-21 days after the last dose of test article
Number of Patients by Microbiologic Response at Test-of-Cure (TOC) Visit.
Time frame: 10-21 days after the last dose of test article

Results and safety

Results posted to the registry on 10 Jun 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tigecycline	236	215
Ceftriaxone Sodium + Metronidazole	231	215

Primary outcome: Number of Clinically Evaluable Patients With Clinical Response of Cure at Test-of-Cure (TOC) Visit.

Time frame: 10-21 days after the last dose of test article. Number. Unit: participants

Measure	Tigecycline n = 189	Ceftriaxone Sodium + Metronidazole n = 187
Value	133	139

Tigecycline vs Ceftriaxone Sodium + Metronidazole: Risk Difference (RD): -4.0 (95% CI -13.1 to 5.1), p = 0.009, t-test, 2 sided

Population analysed: All patients who received ≥1 dose of study drug, who had clinical evidence of complicated intra-abdominal infection, met all inclusion and exclusion criteria, and completed TOC assessment within 8-44 days after last dose of study drug. Patients with an indeterminate assessment were excluded.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tigecycline	51 of ?	195 of ?	Not reported
Ceftriaxone Sodium + Metronidazole	49 of ?	189 of ?	Not reported

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 20670293Towfigh S, Pasternak J, Poirier A, Leister H, Babinchak T. A multicentre, open-label, randomized comparative study of tigecycline versus ceftriaxone sodium plus metronidazole for the treatment of hospitalized subjects with complicated intra-abdominal infections. Clin Microbiol Infect. 2010 Aug;16(8):1274-81. doi: 10.1111/j.1469-0691.2010.03122.x.

Related trials for Appendicitis

RecruitingObservational study
Prospective Comparison of Pro-Adrenomedullin, C-Reactive Protein, and Neutrophil-to-Lymphocyte Ratio for Diagnosing Acute Appendicitis
Acute Appendicitis
Active, not recruiting
PAINED: Project Addressing INequities in the Emergency Department
Pain, Appendicitis
Not yet recruiting
Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
Appendicitis, Perforated Appendicitis
Recruiting
Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Acute Appendicitis
RecruitingPhase 3
Laparoscopic Antibiotic Lavage to Prevent Intra-abdominal Abscess Formation in Complicated Appendicitis
Complicated Appendicitis, Intra-Abdominal Abscess

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

66 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 66 sites in United States, Canada, Argentina, Brazil, Chile and 1 more country. 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 10 Jun 2009). 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 Patients With Clinical Response of Cure at Test-of-Cure (TOC) Visit. (time frame: 10-21 days after the last dose of test article). 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 NCT00195351, 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.