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Also known as DFA-02 Antibiotic Gel
DFA-02 Antibiotic · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| DFA-02 Antibiotic Gel | EXPERIMENTAL | Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure. |
| DFA-02 Placebo Gel | PLACEBO_COMPARATOR | Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure. |
| Standard of Care | NO_INTERVENTION | Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied. |
| Name | Type | Description |
|---|---|---|
| DFA-02 Antibiotic Gel | DRUG | - |
| DFA-02 Placebo Gel | DRUG | - |
Inclusion Criteria: 1. Males and females 18 years of age or older; 2. If female, the subject must be postmenopausal, surgically sterilized or, if of child-bearing potential, she must have a negative serum or urine pregnancy test within 48 hours of surgery and agree to use adequate birth control dur...
DFA-02 Antibiotic is being developed for the prevention of surgical site infections in patients undergoing abdominal surgery. It is a small molecule anti-infective candidate studied in a Phase 2 clinical trial in the United States. Surgical site infections are the target indication in the infectious disease therapeutic area.
DFA-02 Antibiotic is being developed by Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY. The company sponsored the Phase 2 clinical study of the candidate in patients undergoing abdominal surgery. Dr. Reddy's Laboratories is the developer associated with this asset.
DFA-02 Antibiotic is in Phase 2 clinical development. One Phase 2 trial has been completed, and no trials are currently active. The drug is investigational and has not been approved by the FDA for any indication based on the available development record.
DFA-02 Antibiotic has been studied in one completed Phase 2 trial, NCT01888367, titled a safety, efficacy and tolerability study of up to 20 mL of DFA-02 in patients undergoing abdominal surgery. The trial enrolled 445 patients in the United States, was randomized, double blind, and placebo controlled.
Yes, DFA-02 Antibiotic Gel is another name for DFA-02 Antibiotic. Both names refer to the same investigational small molecule developed by Dr. Reddy's Laboratories Ltd for surgical site infections. Readers searching for either name are looking at the same Phase 2 asset.
The completed Phase 2 trial of DFA-02 Antibiotic, NCT01888367, enrolled 445 patients. Participants were 18 years of age or older, of all sexes, and were undergoing abdominal surgery. The study was randomized, double blind, and placebo controlled, and it did not enroll healthy volunteers.