Trial Outcomes & Findings for Cefixime for Alternative Syphilis Treatment (NCT NCT03660488)
NCT ID: NCT03660488
Last Updated: 2022-07-26
Results Overview
subjects who have a 4-fold decrease (from study entry Rapid plasma reagin) in Rapid plasma reagintiters from baseline at 3 or 6 months will be considered a positive treatment response.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
58 participants
Primary outcome timeframe
3 or 6 months after treatment completion
Results posted on
2022-07-26
Participant Flow
Participant milestones
| Measure |
Benzathine Penicillin G
Patients of the "Penicillin Group" will receive the standard of care treatment. This is one intramuscular injection of 2.4 million units Benzathine Penicillin G. The group will consist of 50 patients.
Benzathine Penicillin G: The control group will receive Benzathine Penicillin G 2.4 Million Units intramuscularly for treatment of syphilis. Penicillin is the indicated treatment for syphilis infection
|
Cefixime Group
Patients of the "Cefixime Group" will receive Cefixime 400 mg, per os, one tablet, two times per day, for ten consecutive days. The study team will provide the medication.
The group will consist of 50 patients.
Cefixime 400 milligram Oral Capsule \[Suprax\]: The intervention group will receive Cefixime 400mg, one tablet twice per day, for ten consecutive days
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
27
|
|
Overall Study
COMPLETED
|
31
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cefixime for Alternative Syphilis Treatment
Baseline characteristics by cohort
| Measure |
Benzathine Penicillin G
n=31 Participants
Patients of the "Penicillin Group" will receive the standard of care treatment. This is one intramuscular injection of 2.4 million units Benzathine Penicillin G. The group will consist of 50 patients.
Benzathine Penicillin G: The control group will receive Benzathine Penicillin G 2.4 Million Units intramuscularly for treatment of syphilis. Penicillin is the indicated treatment for syphilis infection
|
Cefixime Group
n=27 Participants
Patients of the "Cefixime Group" will receive Cefixime 400 mg, per os, one tablet, two times per day, for ten consecutive days. The study team will provide the medication.
The group will consist of 50 patients.
Cefixime 400 milligram Oral Capsule \[Suprax\]: The intervention group will receive Cefixime 400mg, one tablet twice per day, for ten consecutive days
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Age, Continuous
|
39 years
n=99 Participants
|
39 years
n=107 Participants
|
39 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Hispanic/Latinx, or Spanish Origin
|
19 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Non-Hispanic African American
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Non-Hispanic White
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Non-Hispanic Asian/Hawaiian/Pacific Islander
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
31 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 3 or 6 months after treatment completionsubjects who have a 4-fold decrease (from study entry Rapid plasma reagin) in Rapid plasma reagintiters from baseline at 3 or 6 months will be considered a positive treatment response.
Outcome measures
| Measure |
Benzathine Penicillin G
n=15 Participants
Patients of the "Penicillin Group" will receive the standard of care treatment. This is one intramuscular injection of 2.4 million units Benzathine Penicillin G. The group will consist of 50 patients.
Benzathine Penicillin G: The control group will receive Benzathine Penicillin G 2.4 Million Units intramuscularly for treatment of syphilis. Penicillin is the indicated treatment for syphilis infection
|
Cefixime Group
n=15 Participants
Patients of the "Cefixime Group" will receive Cefixime 400 mg, per os, one tablet, two times per day, for ten consecutive days. The study team will provide the medication.
The group will consist of 50 patients.
Cefixime 400 milligram Oral Capsule \[Suprax\]: The intervention group will receive Cefixime 400mg, one tablet twice per day, for ten consecutive days
|
|---|---|---|
|
Treatment Response
|
14 Participants
|
13 Participants
|
Adverse Events
Benzathine Penicillin G
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cefixime Group
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Benzathine Penicillin G
n=31 participants at risk
Patients of the "Penicillin Group" will receive the standard of care treatment. This is one intramuscular injection of 2.4 million units Benzathine Penicillin G. The group will consist of 50 patients.
Benzathine Penicillin G: The control group will receive Benzathine Penicillin G 2.4 Million Units intramuscularly for treatment of syphilis. Penicillin is the indicated treatment for syphilis infection
|
Cefixime Group
n=27 participants at risk
Patients of the "Cefixime Group" will receive Cefixime 400 mg, per os, one tablet, two times per day, for ten consecutive days. The study team will provide the medication.
The group will consist of 50 patients.
Cefixime 400 milligram Oral Capsule \[Suprax\]: The intervention group will receive Cefixime 400mg, one tablet twice per day, for ten consecutive days
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Mild Skin Rash
|
0.00%
0/31 • Adverse event data were collected throughout the duration of the study (12 months) starting from enrollment. Evaluation for adverse events occurred during follow ups; for the cefixime group we evaluated adverse events during the 10-day visit. Participants and study clinicians were instructed to report any occurrence to the study team for review.
In case of an adverse event, participants were instructed to contact the study team. The team had provided necessary clinic and study team contact informaion
|
3.7%
1/27 • Number of events 1 • Adverse event data were collected throughout the duration of the study (12 months) starting from enrollment. Evaluation for adverse events occurred during follow ups; for the cefixime group we evaluated adverse events during the 10-day visit. Participants and study clinicians were instructed to report any occurrence to the study team for review.
In case of an adverse event, participants were instructed to contact the study team. The team had provided necessary clinic and study team contact informaion
|
Other adverse events
Adverse event data not reported
Additional Information
Jeffrey D Klausner MD MPH, Clinical Professor of Population and Public Health Sciences
University of Southern California
Phone: 4158768901
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place