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DFA-02 Antibiotic

Phase 2

Surgical Site Infections | Small molecule | Infectious Disease |Dr. Reddy's Laboratories Ltd|Last Updated: Oct 11, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment445

FDA Designations

No designations recorded

Clinical trial landscape

DFA-02 Antibiotic · 1 trial · 1 indication

Phase 2 1
NCT01888367Safety, Efficacy and Tolerability Study of up to 20 mL of DFA-02 in Patients Undergoing Abdominal SurgerySurgical Site Infections
COMPLETED445 Analytics
PHASE2COMPLETED
Safety, Efficacy and Tolerability Study of up to 20 mL of DFA-02 in Patients Undergoing Abdominal Surgery
Surgical Site InfectionsUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Patients With Surgical Site Infections
Within 30 days of surgery

Secondary Endpoints

Number of Patients With Adverse Events
Within 30 days of surgery
Change in Serum Creatinine Measurements From Baseline
Within 4 days of surgery
Cumulative ASEPSIS Score for Each Patient
Through post-operative Day 4
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
DFA-02 Antibiotic GelEXPERIMENTALUp 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 GelPLACEBO_COMPARATORUp 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 CareNO_INTERVENTIONPrior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.

Interventions

NameTypeDescription
DFA-02 Antibiotic GelDRUG -
DFA-02 Placebo GelDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites31

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...

Countries:United States
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Frequently asked questions about DFA-02 Antibiotic

What is DFA-02 Antibiotic used for?

DFA-02 Antibiotic is an investigational small molecule being developed for the prevention of Surgical Site Infections. It is administered during abdominal surgery to reduce the risk of infection at the surgical site. The drug is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.

Who makes DFA-02 Antibiotic?

DFA-02 Antibiotic is being developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company listed on the stock exchange under the ticker symbol RDY. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational antibiotic for Surgical Site Infections.

What phase is DFA-02 Antibiotic in?

DFA-02 Antibiotic is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory agencies. The drug is being studied for its safety, efficacy, and tolerability in patients undergoing abdominal surgery to prevent Surgical Site Infections.

What clinical trials is DFA-02 Antibiotic in?

DFA-02 Antibiotic has one completed Phase 2 clinical trial registered as NCT01888367. This study evaluated the safety, efficacy, and tolerability of up to 20 mL of DFA-02 in 445 patients undergoing abdominal surgery in the United States. The trial was randomized, double-blind, and placebo-controlled.

How does DFA-02 Antibiotic work?

DFA-02 Antibiotic is a small molecule antibiotic designed to prevent Surgical Site Infections. It is administered locally during abdominal surgery to target and eliminate bacteria at the surgical site, reducing the risk of postoperative infection. The specific molecular target of this drug has not been disclosed.

Is DFA-02 Antibiotic the same as any other drug?

DFA-02 Antibiotic is a distinct investigational drug candidate developed by Dr. Reddy's Laboratories. No alternative names or brand names have been associated with this compound in the available clinical trial information. It is being studied specifically for the prevention of Surgical Site Infections.