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Antibiotic

Clindamycin for Burns

Phase 4
Waitlist Available
Research Sponsored by Medstar Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-3 days from surgery
Awards & highlights
Approved for 10 Other Conditions
All Individual Drugs Already Approved
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing if giving antibiotics during surgery can help reduce bacteria in burn wounds. It targets patients with burn wounds undergoing surgery. The antibiotics are given through an IV to kill bacteria and prevent infections.

Eligible Conditions
  • Infected Wounds
  • Burns
  • Surgery

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-3 days from surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-3 days from surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
burn wound bacterial concentration

Side effects data

From 2013 Phase 4 trial • 472 Patients • NCT02141217
11%
Alanine aminotransferase increased
10%
Aspartate aminotransferase increased
8%
Diarrhoea
8%
Increased appetite
8%
Somnolence
8%
Dizziness
5%
Blood bilirubin increased
5%
Abdominal discomfort
3%
Headache
3%
Aspartate aminotransferase decreased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Amoxicillin 875 mg + Clavulanic Acid 125 mg
Clindamycin 150 mg

Awards & Highlights

Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: AntibioticsExperimental Treatment2 Interventions
Patients randomized to the treatment arm of the study will have orders placed by a physician on the clinical team, with preparation and delivery of the antibiotics dose by the pharmacy following standard procedures. Antibiotic administration will occur after induction of anesthesia, with delivery by the Anesthesia staff no more than one hour prior to incision. Those with known allergy to beta-lactams will receive clindamycin instead of cefazolin.
Group II: Standard of CareActive Control1 Intervention
Patients randomized to the standard of care arm of the study will receive no perioperative antibiotic administration and will proceed with routine pre-operative care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Clindamycin
FDA approved
Cefazolin
FDA approved

Find a Location

Who is running the clinical trial?

Medstar Health Research InstituteLead Sponsor
195 Previous Clinical Trials
183,127 Total Patients Enrolled
4 Trials studying Burns
92 Patients Enrolled for Burns
~4 spots leftby Nov 2025
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