Trial Outcomes & Findings for DFA-02 in Patients Undergoing Colorectal Surgery (NCT NCT01496352)
NCT ID: NCT01496352
Last Updated: 2014-09-01
Results Overview
Safety and tolerability measured by number of patients with adverse events or changes in laboratory or physical examination findings from baseline (DFA-02 application during surgery on Day 1) to 30 days after surgery.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
30 participants
Primary outcome timeframe
Baseline up to Day 30
Results posted on
2014-09-01
Participant Flow
Study Period: February 12, 2012 to June 27, 2013. Patients were enrolled at four hospital based sites in the US (Tampa, FL; Temple, Tx; Florence, AL; Houston, TX).
Participant milestones
| Measure |
DFA-02
Progressive cohorts of 8 subjects per cohort receiving up to 10, 20 or 30 mL of DFA-02
DFA-02: Modified release product containing gentamicin and vancomycin for application at the conclusion of surgery after closure of the fascia and prior to skin closure
|
DFA-02 Placebo
Progressive cohorts of 2 patients per cohort receiving up to 10, 20 or 30 mL of DFA-02 placebo
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
6
|
|
Overall Study
COMPLETED
|
24
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
DFA-02 in Patients Undergoing Colorectal Surgery
Baseline characteristics by cohort
| Measure |
DFA-02
n=24 Participants
Progressive cohorts of 8 subjects per cohort receiving up to 10, 20 or 30 mL of DFA-02
|
DFA-02 Placebo
n=6 Participants
Progressive cohorts of 2 subjects per cohort receiving up to 10, 20 or 30 mL of DFA-02 placebo
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.8 years
STANDARD_DEVIATION 14.91 • n=5 Participants
|
58.5 years
STANDARD_DEVIATION 16.7 • n=7 Participants
|
62.0 years
STANDARD_DEVIATION 15.04 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
21 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
6 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Body Mass Index
|
29.8 kg/m2
STANDARD_DEVIATION 4.00 • n=5 Participants
|
27.8 kg/m2
STANDARD_DEVIATION 2.47 • n=7 Participants
|
29.4 kg/m2
STANDARD_DEVIATION 3.79 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 30Population: As Treated
Safety and tolerability measured by number of patients with adverse events or changes in laboratory or physical examination findings from baseline (DFA-02 application during surgery on Day 1) to 30 days after surgery.
Outcome measures
| Measure |
DFA-02
n=24 Participants
Progressive cohorts of 8 subjects receiving up to 10, 20 or 30 mL of DFA-02
|
DFA-02 Placebo
n=6 Participants
Progressive cohorts of 2 subjects receiving 10, 20 or 30 mL of DFA-02 placebo
|
|---|---|---|
|
Number of Patients With Adverse Events, Laboratory, Physical Examination Changes
Any Adverse Event
|
23 Participants
|
6 Participants
|
|
Number of Patients With Adverse Events, Laboratory, Physical Examination Changes
Any Serious Adverse Event
|
5 Participants
|
2 Participants
|
|
Number of Patients With Adverse Events, Laboratory, Physical Examination Changes
Related Adverse Event
|
3 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events, Laboratory, Physical Examination Changes
Death
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 1, 6, 24, 48 96 hours post-dosePopulation: All Subjects Receiving Active Drug
Area under the curve (AUC) of plasma gentamicin and vancomycin levels using sparse sampling from baseline (DFA-02 application during surgery on Day 1) to 4 days after surgery
Outcome measures
| Measure |
DFA-02
n=24 Participants
Progressive cohorts of 8 subjects receiving up to 10, 20 or 30 mL of DFA-02
|
DFA-02 Placebo
Progressive cohorts of 2 subjects receiving 10, 20 or 30 mL of DFA-02 placebo
|
|---|---|---|
|
Area Under Curve (AUC)
Gentamicin AUC (0-t)
|
14.2 mcg/h/mL
Standard Deviation 12.6
|
—
|
|
Area Under Curve (AUC)
Vancomycin AUC (0-t)
|
6.47 mcg/h/mL
Standard Deviation 8.12
|
—
|
SECONDARY outcome
Timeframe: 1, 6, 24, 48, 96 hours post-dosePopulation: All subjects receiving DFA-02 active gel
Maximal plasma concentration (Cmax)of gentamicin and vancomycin using sparse sampling from baseline (DFA-02 application during surgery on Day 1) to 4 days after surgery
Outcome measures
| Measure |
DFA-02
n=24 Participants
Progressive cohorts of 8 subjects receiving up to 10, 20 or 30 mL of DFA-02
|
DFA-02 Placebo
Progressive cohorts of 2 subjects receiving 10, 20 or 30 mL of DFA-02 placebo
|
|---|---|---|
|
Maximal Plasma Concentration (Cmax)
Gentamicin Cmax
|
0.642 mcg/mL
Standard Deviation 0.524
|
—
|
|
Maximal Plasma Concentration (Cmax)
Vancomycin Cmax
|
0.164 mcg/mL
Standard Deviation 0.150
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Day 14Population: As treated
Changes in serum creatinine from surgery on Day 1 until 14 days after surgery
Outcome measures
| Measure |
DFA-02
n=24 Participants
Progressive cohorts of 8 subjects receiving up to 10, 20 or 30 mL of DFA-02
|
DFA-02 Placebo
n=6 Participants
Progressive cohorts of 2 subjects receiving 10, 20 or 30 mL of DFA-02 placebo
|
|---|---|---|
|
Renal Function
Moderate Elevated Serum Creatinine Day 5 or Day 14
|
1 Participants
|
0 Participants
|
|
Renal Function
Severe/LifeThreatening Elevated Serum Creatinine
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 5Population: As Treated
Methicillin-resistant Staphylococcus aureus and vancomycin-resistant enterococcus presence at surgery on Day 1 and 5 days after surgery
Outcome measures
| Measure |
DFA-02
n=24 Participants
Progressive cohorts of 8 subjects receiving up to 10, 20 or 30 mL of DFA-02
|
DFA-02 Placebo
n=6 Participants
Progressive cohorts of 2 subjects receiving 10, 20 or 30 mL of DFA-02 placebo
|
|---|---|---|
|
Antibiotic Resistance
Nasal MRSA Conversion
|
1 Participants
|
0 Participants
|
|
Antibiotic Resistance
Rectal Vancomycin Resistant Enterococcus Conversio
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 30 Days After SurgeryPopulation: As treated
The incidence of probable or definite surgical site infection as determined by the Investigator.
Outcome measures
| Measure |
DFA-02
n=24 Participants
Progressive cohorts of 8 subjects receiving up to 10, 20 or 30 mL of DFA-02
|
DFA-02 Placebo
n=6 Participants
Progressive cohorts of 2 subjects receiving 10, 20 or 30 mL of DFA-02 placebo
|
|---|---|---|
|
Incidence of Surgical Site Infection
|
6 Participants
|
1 Participants
|
Adverse Events
DFA-02
Serious events: 5 serious events
Other events: 23 other events
Deaths: 0 deaths
DFA-02 Placebo
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DFA-02
n=24 participants at risk
Progressive cohorts of 8 subjects per cohort receiving up to 10, 20 or 30 mL of DFA-02
|
DFA-02 Placebo
n=6 participants at risk
Progressive cohorts of 2 subjects per cohort receiving up to 10, 20 or 30 mL of DFA-02 placebo
|
|---|---|---|
|
Gastrointestinal disorders
Bowel Obstruction
|
4.2%
1/24 • Number of events 1 • From Informed Consent to 30 Days After Surgery
|
0.00%
0/6 • From Informed Consent to 30 Days After Surgery
|
|
Injury, poisoning and procedural complications
Anastomotic Leak
|
4.2%
1/24 • Number of events 1 • From Informed Consent to 30 Days After Surgery
|
0.00%
0/6 • From Informed Consent to 30 Days After Surgery
|
|
Injury, poisoning and procedural complications
Surgical Site Infection
|
4.2%
1/24 • Number of events 1 • From Informed Consent to 30 Days After Surgery
|
16.7%
1/6 • Number of events 1 • From Informed Consent to 30 Days After Surgery
|
|
Injury, poisoning and procedural complications
Post-operative Bleeding
|
4.2%
1/24 • Number of events 1 • From Informed Consent to 30 Days After Surgery
|
0.00%
0/6 • From Informed Consent to 30 Days After Surgery
|
|
Injury, poisoning and procedural complications
Anastomotic Dehiscence
|
4.2%
1/24 • Number of events 1 • From Informed Consent to 30 Days After Surgery
|
0.00%
0/6 • From Informed Consent to 30 Days After Surgery
|
|
Injury, poisoning and procedural complications
Death
|
0.00%
0/24 • From Informed Consent to 30 Days After Surgery
|
16.7%
1/6 • Number of events 1 • From Informed Consent to 30 Days After Surgery
|
Other adverse events
| Measure |
DFA-02
n=24 participants at risk
Progressive cohorts of 8 subjects per cohort receiving up to 10, 20 or 30 mL of DFA-02
|
DFA-02 Placebo
n=6 participants at risk
Progressive cohorts of 2 subjects per cohort receiving up to 10, 20 or 30 mL of DFA-02 placebo
|
|---|---|---|
|
Blood and lymphatic system disorders
Blood and Lymphatic System Disorders
|
33.3%
8/24 • Number of events 8 • From Informed Consent to 30 Days After Surgery
|
33.3%
2/6 • Number of events 2 • From Informed Consent to 30 Days After Surgery
|
|
Cardiac disorders
Cardiac Disorders
|
37.5%
9/24 • Number of events 9 • From Informed Consent to 30 Days After Surgery
|
33.3%
2/6 • Number of events 2 • From Informed Consent to 30 Days After Surgery
|
|
Gastrointestinal disorders
Gastrointestinal Disorders
|
87.5%
21/24 • Number of events 21 • From Informed Consent to 30 Days After Surgery
|
83.3%
5/6 • Number of events 5 • From Informed Consent to 30 Days After Surgery
|
|
General disorders
General Disorders and Administration Site Conditions
|
16.7%
4/24 • Number of events 4 • From Informed Consent to 30 Days After Surgery
|
16.7%
1/6 • Number of events 1 • From Informed Consent to 30 Days After Surgery
|
|
Hepatobiliary disorders
Hepatobiliary Disorders
|
4.2%
1/24 • Number of events 1 • From Informed Consent to 30 Days After Surgery
|
0.00%
0/6 • From Informed Consent to 30 Days After Surgery
|
|
Infections and infestations
Infections and Infestations
|
41.7%
10/24 • Number of events 10 • From Informed Consent to 30 Days After Surgery
|
16.7%
1/6 • Number of events 1 • From Informed Consent to 30 Days After Surgery
|
|
Injury, poisoning and procedural complications
Injury, Poisoning and Procedural Complications
|
37.5%
9/24 • Number of events 9 • From Informed Consent to 30 Days After Surgery
|
33.3%
2/6 • Number of events 2 • From Informed Consent to 30 Days After Surgery
|
|
Investigations
Investigations
|
50.0%
12/24 • Number of events 12 • From Informed Consent to 30 Days After Surgery
|
50.0%
3/6 • Number of events 3 • From Informed Consent to 30 Days After Surgery
|
|
Metabolism and nutrition disorders
Metabolism and Nutritional Disorders
|
45.8%
11/24 • Number of events 11 • From Informed Consent to 30 Days After Surgery
|
33.3%
2/6 • Number of events 2 • From Informed Consent to 30 Days After Surgery
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and Connective Tissue Disorders
|
8.3%
2/24 • Number of events 2 • From Informed Consent to 30 Days After Surgery
|
16.7%
1/6 • Number of events 1 • From Informed Consent to 30 Days After Surgery
|
|
Nervous system disorders
Nervous System Disorders
|
12.5%
3/24 • Number of events 3 • From Informed Consent to 30 Days After Surgery
|
16.7%
1/6 • Number of events 1 • From Informed Consent to 30 Days After Surgery
|
|
Psychiatric disorders
Psychiatric Disorders
|
20.8%
5/24 • Number of events 5 • From Informed Consent to 30 Days After Surgery
|
0.00%
0/6 • From Informed Consent to 30 Days After Surgery
|
|
Renal and urinary disorders
Renal and Urinary Disorders
|
16.7%
4/24 • Number of events 4 • From Informed Consent to 30 Days After Surgery
|
16.7%
1/6 • Number of events 1 • From Informed Consent to 30 Days After Surgery
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, Thoracic and Mediastinal Disorders
|
20.8%
5/24 • Number of events 5 • From Informed Consent to 30 Days After Surgery
|
16.7%
1/6 • Number of events 1 • From Informed Consent to 30 Days After Surgery
|
|
Skin and subcutaneous tissue disorders
Skin and Subcutaneous Disorders
|
12.5%
3/24 • Number of events 3 • From Informed Consent to 30 Days After Surgery
|
16.7%
1/6 • Number of events 1 • From Informed Consent to 30 Days After Surgery
|
|
Vascular disorders
Vascular Disorders
|
54.2%
13/24 • Number of events 13 • From Informed Consent to 30 Days After Surgery
|
33.3%
2/6 • Number of events 2 • From Informed Consent to 30 Days After Surgery
|
Additional Information
Kent Allenby, MD, VP, Drug Development
Dr. Reddy's Laboratories, Inc.
Phone: 609-375-9855
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60