Trial Outcomes & Findings for Syphilis Response to Higher Penicillin Dosage: The 2.4 Versus 7.2 Study (NCT NCT02611765)
NCT ID: NCT02611765
Last Updated: 2016-05-17
Results Overview
Number of participants who achieve treatment success. Loss to follow-up was assumed to be a failure.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
64 participants
Primary outcome timeframe
12 months
Results posted on
2016-05-17
Participant Flow
Participant milestones
| Measure |
Enhanced Therapy
Three doses of 2.4 million units of intramuscular benzathine penicillin G administered weekly (a total of 7.2 million units)
Enhanced therapy: Three doses of intramuscular 2.4 million units of benzathine penicillin G administered weekly (a total of 7.2 million units).
|
Standard Therapy
A single intramuscular injection of 2.4 million units of benzathine penicillin G
Standard therapy: A single dose of intramuscular 2.4 million units of benzathine penicillin G
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
35
|
|
Overall Study
COMPLETED
|
27
|
29
|
|
Overall Study
NOT COMPLETED
|
2
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Syphilis Response to Higher Penicillin Dosage: The 2.4 Versus 7.2 Study
Baseline characteristics by cohort
| Measure |
Enhanced Therapy
n=29 Participants
Three doses of 2.4 million units of intramuscular benzathine penicillin G administered weekly (a total of 7.2 million units)
Enhanced therapy: Three doses of intramuscular 2.4 million units of benzathine penicillin G administered weekly (a total of 7.2 million units).
|
Standard Therapy
n=35 Participants
A single intramuscular injection of 2.4 million units of benzathine penicillin G
Standard therapy: A single dose of intramuscular 2.4 million units of benzathine penicillin G
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35 years
STANDARD_DEVIATION 11 • n=5 Participants
|
35 years
STANDARD_DEVIATION 10 • n=7 Participants
|
35 years
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Whites
|
1 participants
n=5 Participants
|
6 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African Americans
|
15 participants
n=5 Participants
|
22 participants
n=7 Participants
|
37 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanics
|
13 participants
n=5 Participants
|
7 participants
n=7 Participants
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsNumber of participants who achieve treatment success. Loss to follow-up was assumed to be a failure.
Outcome measures
| Measure |
Enhanced Therapy
n=29 Participants
Three doses of 2.4 million units of intramuscular benzathine penicillin G administered weekly (a total of 7.2 million units)
Enhanced therapy: Three doses of intramuscular 2.4 million units of benzathine penicillin G administered weekly (a total of 7.2 million units).
|
Standard Therapy
n=35 Participants
A single intramuscular injection of 2.4 million units of benzathine penicillin G
Standard therapy: A single dose of intramuscular 2.4 million units of benzathine penicillin G
|
|---|---|---|
|
Treatment Success Defined as a Decrease in Rapid Plasma Reagin (RPR) Titer of >= 2 Dilutions (4-fold)
|
27 participants
|
28 participants
|
Adverse Events
Enhanced Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place