Completed

FAST2A Phase 2, Randomized, Double-Blind, Multinational Trial of Intravenous Telavancin Versus Standard Therapy for Treatment of Complicated Gram-Positive Skin and Skin Structure Infections (Gram Positive cSSSI)

What is being tested

Telavancin

+ vancomycin or antistaphylococcal penicillin

Drug

Who is being recruted

Abscess+14

+ Bacterial Infections and Mycoses

+ Bacterial Infections

Over 18 Years

+4 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2

Interventional

Study Start: February 2004

See protocol details

Summary

Principal SponsorCumberland Pharmaceuticals

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2004

Actual date on which the first participant was enrolled.

Serious infections caused by resistant bacteria are becoming more of a medical problem throughout the world. This study will measure how well TD-6424 (Telavancin) can control infections and whether the drug is safe to give to patients.

Official TitleA Phase 2, Randomized, Double-Blind, Multinational Trial of Intravenous Telavancin Versus Standard Therapy for Treatment of Complicated Gram-Positive Skin and Skin Structure Infections (Gram Positive cSSSI)

NCT00077675

Principal SponsorCumberland Pharmaceuticals

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

201 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AbscessBacterial Infections and MycosesBacterial InfectionsBurnsCellulitisConnective Tissue DiseasesInfectionsInflammationPathologic ProcessesSkin Diseases, InfectiousSuppurationPathological Conditions, Signs and SymptomsUlcerWound InfectionWounds and InjuriesGram-Positive Bacterial InfectionsSkin and Connective Tissue Diseases

Criteria

2 inclusion criteria required to participate

Patients must have a diagnosis of one of the following complicated skin and soft tissue infections and either a suspected or confirmed Gram positive organism: major abscess requiring surgical incision and drainage, infected burn (see exclusion criteria for important qualifications), deep/extensive cellulitis, infected ulcer (see exclusion criteria for important qualifications), wound infection

Patients must be expected to require at least 4 days of intravenous (IV) antibiotic treatment

2 exclusion criteria prevent from participating

Previous systemic antibacterial therapy (with the exception of aztreonam and metronidazole) for > 24 hours within 7 days prior to the first dose of study drug unless the pathogen was resistant to prior treatment or the patient was a treatment failure (no clinical improvement after 3 days)

Burns involving > 20% of body surface area or third degree/full thickness in nature, diabetic foot ulcers, ischemic ulcers/wounds, necrotizing fasciitis, gas gangrene, or mediastinitis

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Group II

Active Comparator

cSSSI - comlicated skin and skin structure infections

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Paradise Valley Hospital, 2400 E. 4th Street

National City, United StatesOpen Paradise Valley Hospital, 2400 E. 4th Street in Google Maps

CompletedOne Study Center