Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00261807 · ClinicalTrials.gov registry record · NA
Daptomycin for the Treatment of Severe Necrotizing Soft-Tissue Infections
A NA study, sponsored by University of Maryland, Baltimore.
- Completed
- Registry status
- NA
- Development phase
- 25
- Enrollment target
NCT00261807 is a NA study that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 25 participants.
The verdict
NCT00261807, a NA study, has completed, sponsored by University of Maryland, Baltimore.
- COMPLETED
- Registry status
- NA
- Development phase
- 25 participants
- Enrollment target
Study Summary
Daptomycin is a new antimicrobial agent which has activity against resistant Gram positive cocci including MRSA. The phase 3 clinical trials for skin and soft tissue infections (SSTI) with Staphylococci and Streptococci have already demonstrated that daptomycin was noninferior to the comparator agent (vancomycin or beta-lactams) (10). Although this clinical trial did not include any patients with clostridial infection, there is in vitro data to support the activity of daptomycin against a variety of clostridial species(11) ( Clostridium perfringens) Therefore, for this trial we will include patients with clostridial infections with this species. Additionally, the patients in the SSTI study were not as ill as the proposed study population. Therefore for treatment of such severe infections, we would like to use a higher dose of daptomycin (6mg/kg/dose). The reasons for using a higher dose of daptomycin in this subgroup are as follows: 1. Patients who are severely ill have an increased volume of distribution; and therefore have a lower serum concentration of daptomycin. These patients might require a higher dose of daptomycin to achieve the desired serum concentration. 2. One of the organisms involved in necrotizing fasciitis is enterococcus (both-fecalis and faecium). E.faecium has higher MICs to daptomycin and would require a higher dose of the drug to achieve adequate free (unbound) serum concentration of the drug. 3. Both necrotizing fasciitis and endocarditis are serious deep seated infections. The clinical trials for endocarditis are using 6mg/kg/dose of daptomycin. Therefore for optimal treatment of necrotizing fasciitis, it is justifiable that we should use the higher dose of daptomycin. Objective: To evaluate the clinical and microbiological efficacy and safety of higher dose daptomycin therapy in the treatment of patients with severe necrotizing skin and soft tissue infections. Type of Study: Open label, single center study.
Interventions
- DRUG Daptomycin 6mg/kg/day
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2005-06 |
| Est. Completion | 2008-05 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00261807
The ClinicalTrials.gov registry entry for NCT00261807 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Maryland, Baltimore, which has 560 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Daptomycin 6mg/kg/day is the first listed.
NCT00261807 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00261807 about?
NCT00261807 is a clinical study titled "Daptomycin for the Treatment of Severe Necrotizing Soft-Tissue Infections". Daptomycin is a new antimicrobial agent which has activity against resistant Gram positive cocci including MRSA. The phase 3 clinical trials for skin and soft tissue infections (SSTI) with Staphylococci and Streptococci have already demonstrated that daptomycin was noninferior to the comparator agen...
What is the current status of trial NCT00261807?
This trial is currently completed. It is a NA study. The enrollment target is 25 participants. The study started on 2005-06. Estimated completion is 2008-05.
What interventions are being tested in trial NCT00261807?
The interventions under investigation include: Daptomycin 6mg/kg/day (DRUG).
Who is sponsoring clinical trial NCT00261807?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.