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A Clinical Trial to Evaluate the Safety and Efficacy of Ciprofloxacin in the Treatment of Plague in Humans

NCT01243437 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-05-06

No results posted yet for this study

Summary

This study is a randomized, open-label, non-inferiority clinical trial evaluating the safety and efficacy of oral ciprofloxacin compared to oral doxycycline for the treatment of plague in humans. Participants aged 8 years and older with suspected plague presenting to health facilities in Uganda will be enrolled and randomized to receive either ciprofloxacin or doxycycline.

Plague is a severe, potentially fatal infectious disease caused by Yersinia pestis, with high case fatality rates if not promptly treated. Current treatment options include aminoglycosides and tetracyclines such as doxycycline; however, limitations include availability, route of administration, and safety concerns in certain populations. Ciprofloxacin is a widely available fluoroquinolone with favorable pharmacokinetics and demonstrated activity against Y. pestis in vitro and in animal models, but clinical data in humans are limited.

The primary outcome is all-cause mortality within 14 days of enrollment among participants with laboratory-confirmed plague. Secondary outcomes include time to defervescence and antimicrobial-associated adverse events.

This study aims to determine whether ciprofloxacin is non-inferior to doxycycline and to inform treatment guidelines for plague, particularly in resource-limited settings.

Conditions

  • Plague

Interventions

DRUG

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.

DRUG

doxyxcycline

* For adults and children weighing 45 kg or more: 200 mg orally one time as an initial loading dose, followed by 100 mg orally every 12 hours for 10 days or until the patient has been fever-free for 24 hours, whichever is longer; * For children weighing less than 45 kg: 4.4 mg/kg orally one time as an initial loading dose, followed by 2.2 mg/kg orally every 12 hours for 10 days or until the patient has been fever-free for 24 hours, whichever is longer.

Sponsors & Collaborators

Principal Investigators

  • Kevin S. Griffith, MD, MPH · Centers for Disease Control and Prevention

  • Edward Mbidde, MD · MRC/UVRI and LSHTM Uganda Research Unit

  • Issa Makumbi, MD · Ministry of Health, Uganda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • Uganda

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01243437 on ClinicalTrials.gov