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| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment |
| Conditions: |
Appendicitis Cholecystitis Diverticulitis Intra-Abdominal Abscess Intra-abdominal Infection Peritonitis |
| Interventions: |
Drug: tigecycline Drug: ceftriaxone plus metronidazole |
Participant Flow
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| Patients were recruited worldwide from November 2005 to July 2008. |
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| Patients were screened according to the inclusion/exclusion criteria. Once informed consent was obtained, the patient was enrolled into the study and assigned a randomization number and a treatment regimen. |
| Description | |
|---|---|
| Tigecycline | Tigecycline administered IV every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours). |
| Ceftriaxone | Ceftriaxone sodium 2 g administered IV once daily plus metronidazole 1 to 2 g daily in divided IV doses. |
| Tigecycline | Ceftriaxone | |
|---|---|---|
| STARTED | 235 | 238 |
| COMPLETED | 232 | 235 |
| NOT COMPLETED | 3 | 3 |
| No study drug dosed | 3 | 3 |
| Tigecycline | Ceftriaxone | |
|---|---|---|
| STARTED | 232 | 235 |
| COMPLETED | 210 | 216 |
| NOT COMPLETED | 22 | 19 |
| Lost to Follow-up | 5 | 12 |
| Death | 6 | 5 |
| Withdrawal by Subject | 7 | 1 |
| Adverse event | 1 | 0 |
| No bacteria observed | 1 | 0 |
| Failure to return | 1 | 1 |
| Reintervention | 1 | 0 |
Baseline Characteristics
| Description | |
|---|---|
| Tigecycline | Tigecycline administered IV every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours). |
| Ceftriaxone | Ceftriaxone sodium 2 g administered IV once daily plus metronidazole 1 to 2 g daily in divided IV doses. |
| Tigecycline | Ceftriaxone | Total | |
|---|---|---|---|
|
Number of Participants
[units: participants] |
232 | 235 | 467 |
|
Age
[units: years] Mean ± Standard Deviation |
48.55 ± 18.37 | 46.81 ± 18.38 | 47.67 ± 18.37 |
|
Gender
[units: participants] |
|||
| Female | 80 | 72 | 152 |
| Male | 152 | 163 | 315 |
Outcome Measures
| 1. Primary: | Number of Clinically Evaluable (CE) Patients With Clinical Response of Cure at the Test-of-Cure (TOC) Visit [ Time Frame: up to 6 weeks ] |
| 2. Secondary: | Number of Microbiologically Evaluable (ME) Patients With a Clinical Response of Cure at Test-of-Cure (TOC) Visit [ Time Frame: up to 6 weeks ] |
| 3. Secondary: | Number of Microbiologically Evaluable (ME) Patients by Microbiological Response at Test-of-Cure (TOC) Visit [ Time Frame: up to 6 weeks ] |
| 4. Secondary: | Number of Days of Inpatient Healthcare Resource Utilization on or Before Test-of-Cure [ Time Frame: up to 6 weeks ] |
More Information
| Principal Investigators are NOT employed by the organization sponsoring the study. | ||||||
| There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. | ||||||
The agreement is:
|
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| No text entered. |
| Responsible Party: | Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth |
| ClinicalTrials.gov Identifier: | NCT00230971 History of Changes |
| Other Study ID Numbers: | 3074A1-315 |
| Study First Received: | September 30, 2005 |
| Results First Received: | September 30, 2009 |
| Last Updated: | April 5, 2010 |
| Health Authority: | European Union: European Medicines Agency; Australia: Human Research Ethics Committee; Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee; India: Institutional Review Board; Republic of the Philippines: Ethics Committee; Taiwan: Institutional Review Board; Denmark: Ethics Committee; Finland: National Advisory Board on Health Care Ethics; France: Institutional Ethical Committee; Germany: Ethics Commission; Greece: Ethics Committee; Italy: Ethics Committee; Saudi Arabia: Ethics Committee; South Africa: Human Research Ethics Committee; Spain: Ethics Committee; Switzerland: Ethikkommission; Turkey: Ministry of Health; United Kingdom: Research Ethics Committee |