NCT01243437

A Randomized, Non-inferiority, Active Controlled Clinical Trial to Evaluate the Safety and Efficacy of Ciprofloxacin Versus Doxycycline in the Treatment of Plague in Humans

Completed Phase 2 Results posted Last updated 2 June 2026

What this trial tests

Phase 2 trial testing ciprofloxacin in Plague in 5 participants. Completed in 1 June 2013.

Timeline

1 December 2010

Primary endpoint
1 June 2013

1 June 2013

Quick facts

Lead sponsor	Centers for Disease Control and Prevention
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	5
Start date	1 December 2010
Primary completion	1 June 2013
Estimated completion	1 June 2013
Sites	1 location across Uganda

Drugs / interventions tested

• ciprofloxacin (Ciprofloxacin) — full drug profile →
• doxyxcycline — full drug profile →

Conditions studied

• Plague — all drugs for Plague →

Sponsor

Centers for Disease Control and Prevention — full company profile →

Who can join

8 and older, any sex, with Plague. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Number of Participants Achieving Clinical Cure
  Time frame: 14-21 days
  Clinical cure was defined as resolution of clinical symptoms and return to normal activities within 14-21 days after treatment initiation.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Plagued by the Past, Pressed by the Present: A One Health Perspective on <i>Yersinia pestis</i>.
   Ciammaruconi A, Di Spirito M, Pascolini C, Molinari F, et al · · 2025 · PMID 41153833 · DOI 10.3390/biomedicines13102555