Trial Outcomes & Findings for A Clinical Trial to Evaluate the Safety and Efficacy of Ciprofloxacin in the Treatment of Plague in Humans (NCT NCT01243437)
NCT ID: NCT01243437
Last Updated: 2026-06-03
Results Overview
Clinical cure was defined as resolution of clinical symptoms and return to normal activities within 14-21 days after treatment initiation.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
5 participants
Primary outcome timeframe
14-21 days
Results posted on
2026-06-03
Participant Flow
Patients with suspected plague presenting to 6 clinics and 2 hospitals in the West Nile region of Uganda (2011-2014) were screened and enrolled if eligible.
5 patients with culture-confirmed Yersinia pestis infection were enrolled.
Participant milestones
| Measure |
Ciprofloxacin
Participants with suspected or confirmed plague will receive oral ciprofloxacin. Adults and children weighing ≥50 kg will receive 750 mg orally every 12 hours; children weighing \<50 kg will receive 15 mg/kg (maximum 750 mg per dose) orally every 12 hours. Treatment will be administered for 10 days or until the participant has been afebrile for at least 24 hours, whichever is longer.
ciprofloxacin: • For adults and children aged \> 15 years: 500 mg orally every 12 hours for 10 days or until the patient has been fever-free for 24 hours, whichever is longer;
• For children aged 8-15 years: 15 mg/kg (maximum 500 mg per dose) orally every 12 hours for 10 days or until the patient has been fever-free for 24 hours, whichever is longer.
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Clinical Trial to Evaluate the Safety and Efficacy of Ciprofloxacin in the Treatment of Plague in Humans
Baseline characteristics by cohort
| Measure |
Ciprofloxacin
n=5 Participants
Participants with suspected or confirmed plague will receive oral ciprofloxacin. Adults and children weighing ≥50 kg will receive 750 mg orally every 12 hours; children weighing \<50 kg will receive 15 mg/kg (maximum 750 mg per dose) orally every 12 hours. Treatment will be administered for 10 days or until the participant has been afebrile for at least 24 hours, whichever is longer.
ciprofloxacin: • For adults and children aged \> 15 years: 500 mg orally every 12 hours for 10 days or until the patient has been fever-free for 24 hours, whichever is longer;
• For children aged 8-15 years: 15 mg/kg (maximum 500 mg per dose) orally every 12 hours for 10 days or until the patient has been fever-free for 24 hours, whichever is longer.
|
|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=20 Participants
|
|
Age, Continuous
|
27 years
n=20 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=20 Participants
|
|
Region of Enrollment
Uganda
|
5 participants
n=20 Participants
|
PRIMARY outcome
Timeframe: 14-21 daysClinical cure was defined as resolution of clinical symptoms and return to normal activities within 14-21 days after treatment initiation.
Outcome measures
| Measure |
Ciprofloxacin
n=5 Participants
Participants with suspected or confirmed plague will receive oral ciprofloxacin. Adults and children weighing ≥50 kg will receive 750 mg orally every 12 hours; children weighing \<50 kg will receive 15 mg/kg (maximum 750 mg per dose) orally every 12 hours. Treatment will be administered for 10 days or until the participant has been afebrile for at least 24 hours, whichever is longer.
ciprofloxacin: • For adults and children aged \> 15 years: 500 mg orally every 12 hours for 10 days or until the patient has been fever-free for 24 hours, whichever is longer;
• For children aged 8-15 years: 15 mg/kg (maximum 500 mg per dose) orally every 12 hours for 10 days or until the patient has been fever-free for 24 hours, whichever is longer.
|
|---|---|
|
Number of Participants Achieving Clinical Cure
|
5 Participants
|
Adverse Events
Ciprofloxacin
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