Trial · NCT00230971

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

NCT00230971, Phase 4, Completed, Wyeth is now a wholly owned subsidiary of Pfizer; results first posted 2010-04-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection (cIAI). Trials, record NCT00230971. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00230971

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection (cIAI)
NCT number: NCT00230971
Status: Completed
Phases: Phase 4
Enrollment: 473 participants, actual
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Conditions: Appendicitis, Cholecystitis, Diverticulitis, Intra-Abdominal Abscess, Intra-Abdominal Infection, Peritonitis
Interventions: tigecycline, ceftriaxone plus metronidazole
First posted: 2005-10-03
Last updated: 2013-02-25
Results first posted: 2010-04-26

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Clinically Evaluable (CE) Patients With Clinical Response of Cure at the Test-of-Cure (TOC) Visit	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.
Secondary	Number of Microbiologically Evaluable (ME) Patients With a Clinical Response of Cure at Test-of-Cure (TOC) Visit	up to 6 weeks	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.
Secondary	Number of Microbiologically Evaluable (ME) Patients by Microbiological Response at Test-of-Cure (TOC) Visit	up to 6 weeks	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.
Secondary	Number of Days of Inpatient Healthcare Resource Utilization on or Before Test-of-Cure	up to 6 weeks	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

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Clinically Evaluable (CE) Patients With Clinical Response of Cure at the Test-of-Cure (TOC) Visit	up to 6 weeks	All patients who received at least 1 dose of study drug who had clinical evidence of a complicated intra-abdominal infection (cIAI) and completed the test-of-cure (TOC) assessment of cure or failure within 8 to 44 days after the last administration of study article. Patients with an indeterminate assessment were excluded.	participants	NUMBER
SECONDARY	Number of Microbiologically Evaluable (ME) Patients With a Clinical Response of Cure at Test-of-Cure (TOC) Visit	up to 6 weeks	All patients who received ≥1 dose, had clinical evidence of complicated intra-abdominal infection, met all inclusion/exclusion criteria, completed TOC assessment within 8-44 days after last dose, and had a baseline culture with ≥1 identified isolate that was susceptible to both study drugs. Patients with an indeterminate assessment were excluded.	participants	NUMBER
SECONDARY	Number of Microbiologically Evaluable (ME) Patients by Microbiological Response at Test-of-Cure (TOC) Visit	up to 6 weeks	All patients who received ≥1 dose, had clinical evidence of complicated intra-abdominal infection, met all inclusion/exclusion criteria, completed TOC assessment within 8-44 days after last dose, and had a baseline culture with ≥1 identified isolate that was susceptible to both study drugs. Patients with an indeterminate assessment were excluded.	participants	NUMBER
SECONDARY	Number of Days of Inpatient Healthcare Resource Utilization on or Before Test-of-Cure	up to 6 weeks	All patients who received at least 1 dose of study drug.	days	MEAN

Source ClinicalTrials.gov

Results by group18

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Number of Clinically Evaluable (CE) Patients With Clinical Response of Cure at the Test-of-Cure (TOC) Visit	Tigecycline		162	participants
Number of Clinically Evaluable (CE) Patients With Clinical Response of Cure at the Test-of-Cure (TOC) Visit	Ceftriaxone		150	participants
Number of Microbiologically Evaluable (ME) Patients With a Clinical Response of Cure at Test-of-Cure (TOC) Visit	Tigecycline		97	participants
Number of Microbiologically Evaluable (ME) Patients With a Clinical Response of Cure at Test-of-Cure (TOC) Visit	Ceftriaxone		86	participants
Number of Microbiologically Evaluable (ME) Patients by Microbiological Response at Test-of-Cure (TOC) Visit	Tigecycline	Eradication + Presumed Eradication	98	participants
Number of Microbiologically Evaluable (ME) Patients by Microbiological Response at Test-of-Cure (TOC) Visit	Ceftriaxone	Eradication + Presumed Eradication	86	participants
Number of Microbiologically Evaluable (ME) Patients by Microbiological Response at Test-of-Cure (TOC) Visit	Tigecycline	Persistence + Presumed Persistence	21	participants
Number of Microbiologically Evaluable (ME) Patients by Microbiological Response at Test-of-Cure (TOC) Visit	Ceftriaxone	Persistence + Presumed Persistence	22	participants
Number of Microbiologically Evaluable (ME) Patients by Microbiological Response at Test-of-Cure (TOC) Visit	Tigecycline	Superinfection	3	participants
Number of Microbiologically Evaluable (ME) Patients by Microbiological Response at Test-of-Cure (TOC) Visit	Ceftriaxone	Superinfection	0	participants

1 to 10 of 18Source ClinicalTrials.gov

See all 18 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Randomization	STARTED	Tigecycline	235
Randomization	STARTED	Ceftriaxone	238
Randomization	COMPLETED	Tigecycline	232
Randomization	COMPLETED	Ceftriaxone	235
Randomization	NOT COMPLETED	Tigecycline	3
Randomization	NOT COMPLETED	Ceftriaxone	3
Baseline Participants	STARTED	Tigecycline	232
Baseline Participants	STARTED	Ceftriaxone	235
Baseline Participants	COMPLETED	Tigecycline	210
Baseline Participants	COMPLETED	Ceftriaxone	216

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events122

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Nausea	Gastrointestinal disorders	Tigecycline	49	232
other	Nausea	Gastrointestinal disorders	Ceftriaxone	50	235
other	Vomiting	Gastrointestinal disorders	Tigecycline	40	232
other	Vomiting	Gastrointestinal disorders	Ceftriaxone	31	235
other	Diarrhea	Gastrointestinal disorders	Tigecycline	27	232
other	Diarrhea	Gastrointestinal disorders	Ceftriaxone	17	235
other	Constipation	Gastrointestinal disorders	Tigecycline	3	232
other	Constipation	Gastrointestinal disorders	Ceftriaxone	8	235
other	Infection	General disorders	Tigecycline	18	232
other	Infection	General disorders	Ceftriaxone	15	235

1 to 10 of 122Source ClinicalTrials.gov

See all 122 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Tigecycline
Total, all-cause mortality	Ceftriaxone
Total, other adverse events	Tigecycline	173	232
Total, other adverse events	Ceftriaxone	155	235
Total, serious adverse events	Tigecycline	37	232
Total, serious adverse events	Ceftriaxone	38	235

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
22439781	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Tigecycline vs Ceftriaxone: Number of Microbiologically Evaluable (ME) Patients With a Clinical Response of Cure at Test-of-Cure (TOC) Visit	Trial comparisons
Tigecycline vs Ceftriaxone: Number of Clinically Evaluable (CE) Patients With Clinical Response of Cure at the Test-of-Cure (TOC) Visit	Trial comparisons
Tigecycline vs Ceftriaxone: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00230971

GET https://conductscience.org/api/trials/v1/NCT00230971/events?page=2

API reference For AI assistants