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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

All Individual Drugs Already Approved

Drug Has Already Been Approved

Approved for 10 Other Conditions

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-3 days from surgery

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

Diarrhoea

Increased appetite

Somnolence

Dizziness

Blood bilirubin increased

Abdominal discomfort

Headache

Aspartate aminotransferase decreased

100%

80%

60%

40%

20%

Study treatment Arm

Amoxicillin 875 mg + Clavulanic Acid 125 mg

Clindamycin 150 mg

Awards & Highlights

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.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

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

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