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NCT00730028 · ClinicalTrials.gov registry record · Phase 2
Uncomplicated Skin and Soft Tissue Infections Caused by Community-Associated Methicillin-Resistant Staphylococcus Aureus
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 1,310
- Enrollment target
NCT00730028: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00730028 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 1,310 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (885% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00730028, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 1,310 participants
- Enrollment target
Study Summary
The purpose of this clinical trial is to evaluate 2 different antibiotics, drugs that fight bacteria, \[clindamycin (CLINDA) and trimethoprim-sulfamethoxazole (TMP-SMX)\] and wound care for the outpatient management of uncomplicated skin and soft tissue infections (uSSTIs) in children and adults. The study will occur in areas where community associated methicillin-resistant Staphylococcus (S.) aureus are common. S. aureus is a type of bacteria. A total of 1310 volunteers, greater than or equal to 6 months of age and adults 85 years or younger, non-immunocompromised, with uSSTIs (in particular abscess and/or cellulitis) will be enrolled in this study. Subjects will be treated with one of the following: CLINDA, TMP-SMX, or placebo (contains no medication). Volunteers will be grouped based on the presence of cellulitis or abscess, whether the abscess can be surgically drained, and its size. The subject participation duration for this study is about 6 weeks.
Primary Outcome
Clinical failure is defined as the occurence of any of the following: 1. Lack of resolution at the Test of Cure (TOC) visit in any or all of the following: erythema, tenderness, purulent drainage, swelling, and local warmth. Erythema or tenderness that was considered due the surgical therapy itself (incision and drainage), was not considered to be indicative of clinical failure. 2. Occurrence of a SSTI at another site other than the site(s) under study. 3. Intolerance of study medication or a t
Interventions
- OTHER Placebo
- DRUG Clindamycin
- DRUG Trimethoprim-sulfamethoxazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,310 participants |
| Start Date | 2009-04 |
| Est. Completion | 2015-02 |
| Phase | Phase 2 |
What the finished NCT00730028 record still lists
NCT00730028 is an interventional study that assigns participants to a tested intervention. Its 1,310 participants enrollment target places it among the larger protocols in the corpus, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (885% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00730028 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00730028 about?
NCT00730028 is a clinical study titled "Uncomplicated Skin and Soft Tissue Infections Caused by Community-Associated Methicillin-Resistant Staphylococcus Aureus". The purpose of this clinical trial is to evaluate 2 different antibiotics, drugs that fight bacteria, \[clindamycin (CLINDA) and trimethoprim-sulfamethoxazole (TMP-SMX)\] and wound care for the outpatient management of uncomplicated skin and soft tissue infections (uSSTIs) in children and adults. Th...
What is the current status of trial NCT00730028?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,310 participants. The study started on 2009-04. Estimated completion is 2015-02.
What interventions are being tested in trial NCT00730028?
The interventions under investigation include: Placebo (OTHER), Clindamycin (DRUG), Trimethoprim-sulfamethoxazole (DRUG).
Who is sponsoring clinical trial NCT00730028?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00730028's enrollment target sits among peer trials
1,310 13th of 2000 higher than 1,988 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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