Study Evaluating Tigecycline Versus Ceftriaxone In Complicated Intra-Abdominal Infections & Community Acquired Pneumonia
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| ClinicalTrials.gov Identifier: NCT00914888 |
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Recruitment Status
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Withdrawn
First Posted
: June 5, 2009
Last Update Posted
: June 7, 2012
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Community Acquired Bacterial Pneumonia Complicated Intra-Abdominal Infection | Drug: Tigecycline Drug: cIAI: Ceftriaxone with metronidazole, plus if applicable aminoglycoside Drug: CAP: Ceftriaxone, plus if applicable oral clarithromycin | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 0 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Multicenter, Randomized, And Double-Blind Study To Evaluate The Safety Of Tigecycline Versus A Ceftriaxone Regimen In The Treatment Of Complicated Intra-Abdominal Infections And Community-Acquired Pneumonia In Subjects Of 8-17 Years |
| Study Start Date : | January 2011 |
| Estimated Primary Completion Date : | May 2014 |
| Estimated Study Completion Date : | May 2014 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: A
Tigecycline
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Drug: Tigecycline
Subject with cIAI: Dosing information for subjects 8 to 11 years old is currently under investigation and will be determined later. Subjects 12 to 17 years old will receive tigecycline 50 mg IV every 12 hours, metronidazole placebo IV will be administered every 8 hours. In addition, at the discretion of the investigator, an aminoglycoside placebo IV may also be administered. Other Name: Tygacil
Drug: Tigecycline
Subject with CAP: IV therapy period: Dosing information for subjects 8 to 11 years old is currently under investigation and will be determined later. Subjects 12 to 17 years old will receive tigecycline 50 mg IV every 12h. At the discretion of the investigator oral clarithromycin placebo may be given every 12h. Oral therapy period: If oral switch criteria are met, on or after Day 4 amoxicillin/clavulanate may be prescribed (40 mg/kg per day divided into 3 equal doses, maximum of 500 mg/dose to subjects weighing less than 40 kg and 500 mg every 8h to subjects weighing 40 kg or greater). In addition, if oral clarithromycin or placebo had been given during the IV period, oral clarithromycin may be given every 12h (7.5 mg/kg, maximum dose 500 mg for subjects 8 to 11 years old, 500 mg for subjects 12 to 17 years old). Other Name: Tygacil
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Active Comparator: B
Ceftriaxone regimen
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Drug: cIAI: Ceftriaxone with metronidazole, plus if applicable aminoglycoside
Subject with cIAI: Subjects will receive ceftriaxone 35 mg/kg (maximum of 1 g/dose) IV every 12 hours, metronidazole 10 mg/kg (maximum of 1 g/dose) IV will be administered every 8 hours. In addition, at the discretion of the investigator, an aminoglycoside IV (adjusted dose if necessary) may also be given. Subject with CAP: IV therapy period: Subjects will receive ceftriaxone 35 mg/kg (maximum of 1 g/dose) IV every 12h. At the discretion of the investigator, oral clarithromycin may be given every 12h (7.5 mg/kg, maximum dose 500 mg for subjects 8 to 11 years old, 500 mg for subjects 12 to 17 years old). Oral therapy period: If oral switch criteria are met, on or after Day 4 amoxicillin/clavulanate may be prescribed (40 mg/kg per day divided into 3 equal doses, maximum of 500 mg/dose to subjects weighing less than 40 kg and 500 mg every 8h to subjects weighing 40 kg or greater). In addition, if oral clarithromycin or placebo had been given during the IV period, oral clarithromycin may be given every 12h (7.5 mg/kg, maximum dose 500 mg for subjects 8 to 11 years old, 500 mg for subjects 12 to 17 years old). |
- Clinical efficacy response (cure, failure, or indeterminate) at the test of cure (TOC) visit for 2 co-primary populations: the clinically evaluable (CE) and clinical modified Intent-to-Treat (c-mITT) populations [ Time Frame: 2 to 7 weeks for cIAI and 2 to 5 weeks for CAP ]
- Clinical response at the IV last day of therapy (LDOT) for co-primary populations: the CE and c-mITT populations [ Time Frame: 5 days to 4 weeks for cIAI and 5 days to 2 weeks for CAP ]
- Clinical response at follow up (FUP) visits for co-primary populations: the CE and c-mITT populations [ Time Frame: 5 to 9 weeks for cIAI and 5 to 7 weeks for CAP ]
- Microbiological response at the subject and the pathogen level [ Time Frame: 5 to 9 weeks for cIAI and 5 to 7 weeks for CAP ]
- Response rate by pathogen and minimum inhibitory concentration (MIC) value [ Time Frame: 5 to 9 weeks for cIAI and 5 to 7 weeks for CAP ]
- Response rates for polymicrobial/monomicrobial infections, and susceptibility evaluations [ Time Frame: 5 to 9 weeks for cIAI and 5 to 7 weeks for CAP ]
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| Ages Eligible for Study: | 8 Years to 17 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female subjects 8 to 17 years old. Children with bone maturation less than 8 years old should be enrolled with caution due to potential risk of tooth discoloration.
- Have a diagnosis of a serious infection (complicated intra-abdominal infections [cIAI] or community acquired pneumonia [CAP] as applicable) requiring hospitalization and administration of IV antibiotic therapy.
- Criteria related indication (cIAI or CAP - as applicable), e.g., sign of systemic infection, signs and symptom.
Exclusion Criteria:
- Subject with any concomitant illness/condition that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and/or completion of the study, or could preclude the evaluation of the subject's response (e.g., life expectancy <30 days).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00914888
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
| Responsible Party: | Wyeth is now a wholly owned subsidiary of Pfizer |
| ClinicalTrials.gov Identifier: | NCT00914888 History of Changes |
| Other Study ID Numbers: |
3074K4-3340 B1811003 |
| First Posted: | June 5, 2009 Key Record Dates |
| Last Update Posted: | June 7, 2012 |
| Last Verified: | June 2012 |
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
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children pediatry pneumonia intra-abdominal infection |
Additional relevant MeSH terms:
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Infection Communicable Diseases Pneumonia Intraabdominal Infections Pneumonia, Bacterial Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Bacterial Infections Tigecycline Metronidazole Clarithromycin Ceftriaxone |
Minocycline Amoxicillin-Potassium Clavulanate Combination Anti-Infective Agents Antiprotozoal Agents Antiparasitic Agents Anti-Bacterial Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors beta-Lactamase Inhibitors |