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COMPLETED Phase 4

Study Comparing the Safety and Efficacy of Tigecycline With Ampicillin-Sulbactam or Amoxicillin-Clavulanate to Treat Skin Infections

NCT00368537 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to compare the safety and efficacy of the antibiotic tigecycline with other antibiotics, ampicillin-sulbactam, and amoxicillin-clavulanate in the treatment of a complicated skin and/or skin structure infection (cSSSI).

Conditions Studied

Interventions

  • DRUG Tigecycline
  • DRUG ampicillin-sulbactam

Study Locations (20)

California

  • — Chula Vista
  • — Mission Viejo
  • — National City

Illinois

  • — Decatur
  • — Naperville
  • — Springfield

District of Columbia

  • — Washington D.C.
  • — Washington D.C.

Florida

  • — Orlando
  • — Vero Beach

Massachusetts

  • — Cambridge
  • — Worcester

Arizona

  • — Scottsdale

Arkansas

  • — Jonesboro

Colorado

  • — Denver

Trial Details

FieldValue
Enrollment Target 550 participants
Start Date 2006-09
Est. Completion 2008-09
Phase Phase 4

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00368537

The ClinicalTrials.gov registry entry for NCT00368537 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 550 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wyeth is now a wholly owned subsidiary of Pfizer, which has 31 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Skin Diseases, Bacterial appearing as the primary indexed condition, and to 2 interventions — of which Tigecycline is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00368537 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, Illinois, District of Columbia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00368537 about?

NCT00368537 is a clinical study titled "Study Comparing the Safety and Efficacy of Tigecycline With Ampicillin-Sulbactam or Amoxicillin-Clavulanate to Treat Skin Infections". The purpose of this study is to compare the safety and efficacy of the antibiotic tigecycline with other antibiotics, ampicillin-sulbactam, and amoxicillin-clavulanate in the treatment of a complicated skin and/or skin structure infection (cSSSI).

What is the current status of trial NCT00368537?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 550 participants. The study started on 2006-09. Estimated completion is 2008-09.

What conditions does trial NCT00368537 study?

This clinical trial studies the following conditions: Skin Diseases, Bacterial. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00368537?

The interventions under investigation include: Tigecycline (DRUG), ampicillin-sulbactam (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00368537?

This trial is sponsored by Wyeth is now a wholly owned subsidiary of Pfizer, which has 31 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00368537 being conducted?

This trial has 20 study locations across Arizona, Arkansas, California, Colorado, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial