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COMPLETED Phase 2

Phase 2 Trial of TD 6424 (Telavancin) Versus Standard Therapy for Complicated Gram Positive Skin and Skin Structure Infections (Gram Positive cSSSI)

NCT00061633 · View on ClinicalTrials.gov ↗

Study Summary

Serious infections caused by resistant bacteria are becoming more of a medical problem throughout the world. One of the ways to deal with this problem is to develop new drugs that can control these bacteria. This study will measure how well TD-6424 (Telavancin) can control infections and whether this drug can be safely given to patients.

Interventions

  • DRUG Telavancin
  • DRUG Vancomycin or antistaphylococcal penicillin

Study Locations (1)

California

  • eStudy Site, 3450 Bonita Road, Ste 201 — Chula Vista

Trial Details

FieldValue
Enrollment Target 169 participants
Start Date 2003-06
Est. Completion 2004-01
Phase Phase 2

Sponsor

Cumberland Pharmaceuticals

12 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00061633

The ClinicalTrials.gov registry entry for NCT00061633 describes a study currently listed as completed. It is categorized as Phase 2, 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 169 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cumberland Pharmaceuticals, which has 12 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 6 conditions, with Burns appearing as the primary indexed condition, and to 2 interventions — of which Telavancin 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: NCT00061633 reports 1 study location spanning 1 distinct geographic area — top geographies include California. 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 NCT00061633 about?

NCT00061633 is a clinical study titled "Phase 2 Trial of TD 6424 (Telavancin) Versus Standard Therapy for Complicated Gram Positive Skin and Skin Structure Infections (Gram Positive cSSSI)". Serious infections caused by resistant bacteria are becoming more of a medical problem throughout the world. One of the ways to deal with this problem is to develop new drugs that can control these bacteria. This study will measure how well TD-6424 (Telavancin) can control infections and whether thi...

What is the current status of trial NCT00061633?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 169 participants. The study started on 2003-06. Estimated completion is 2004-01.

What conditions does trial NCT00061633 study?

This clinical trial studies the following conditions: Burns, Ulcer, Abscess, Cellulitis, Infections, Gram-Positive 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 NCT00061633?

The interventions under investigation include: Telavancin (DRUG), Vancomycin or antistaphylococcal penicillin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00061633?

This trial is sponsored by Cumberland Pharmaceuticals, which has 12 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00061633 being conducted?

This trial has 1 study location across California. 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