Status:
COMPLETED
A Clinical Trial to Evaluate the Safety and Efficacy of Ciprofloxacin in the Treatment of Plague in Humans
Lead Sponsor:
Centers for Disease Control and Prevention
Collaborating Sponsors:
MRC/UVRI and LSHTM Uganda Research Unit
Ministry of Health, Uganda
Conditions:
Plague
Eligibility:
All Genders
8+ years
Phase:
PHASE2
Brief Summary
Plague is a severe, life-threatening disease. Plague occurs in focal locations worldwide, but over 95% of human cases reported to WHO are by countries in Africa. The most common clinical manifestation...
Detailed Description
Plague is a life-threatening disease that requires immediate treatment with effective antimicrobials. Drugs with demonstrated efficacy include streptomycin, doxycycline, and to a lesser extent, gentam...
Eligibility Criteria
Inclusion
- Suspect cases of plague will be eligible and will be asked to give consent for study enrollment using the following criteria:
- any person, including women and persons who are minorities, who;
- must be aged 8 years or older, and;
- must have had potential exposure to rodents and/or fleas or contact with a confirmed plague case, and;
- must have a fever of at least 38ºC that developed rapidly, and have at least one of the following:
- One or more buboes, defined as a tender lymph node swelling \> 1cm in diameter, or;
- Clinical suspicion of pneumonic plague (e.g. prostration, cough, increased respiratory rate, hemoptysis and/or purulent sputum), or
- Clinical suspicion of cutaneous plague (lesion)
- Clinical suspicion of plague and epidemiologic link with other cases
Exclusion
- Patients with suspected plague illness will be considered ineligible for the study and will be excluded from study enrollment using the following criteria:
- Any women who is pregnant, or;
- Any woman who is breast-feeding, or;
- Any person aged \< 8 years of age, or;
- Any patient with:
- signs of plague meningitis
- hypotension unresponsive to fluid therapy
- an illness severity score of \> 16 at time of enrollment (see below)
- known allergy to ciprofloxacin or doxycycline
- taken tetracyclines, quinolones, gentamicin, streptomycin, trimethoprim-sulfamethoxazole, or chloramphenicol in the 24 hours preceding study enrollment
- Patients who are pregnant, breast-feeding, or aged \< 8 years will be excluded because doxycycline has a relative contraindication for use in these populations due to drug deposition in calcifying areas of bones and teeth, enamel hypoplasia, and decreased linear skeletal growth rate. \[22, 23\] Please see section 10.2 for additional background describing the reasoning to exclude patients from these populations. Please see section 3.5 for the specifics regarding the timing of urine pregnancy testing.
- The illness severity score is a composite measure adapted from the APACHE-II and Glasgow Coma scores that estimates the severity of a patient's illness at enrollment. Because most clinic locations are remote with little or no laboratory capacity, the illness severity score utilizes only non-biochemical parameters.
- Patients will not be tested for Human Immunodeficiency Virus (HIV), and known or suspected HIV-positive patients will not be excluded.
- Because this study will be conducted in a remote region of Uganda where no prisons are located, the enrollment of prisoners is not applicable to our study. If for some unforeseen reason a prisoner presents to a study clinic location for treatment of suspected plague, the prisoner will be excluded from the trial.
- All study resources will be available and treatment following the UMOH national plague treatment guidelines will be offered to patients with suspected plague at the UMOH collaborating clinics who are not eligible for enrollment or who declined to consent.
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01243437
Start Date
December 1 2010
End Date
June 1 2013
Last Update
April 24 2025
Active Locations (1)
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1
Uganda Ministry of Health: selected Arua and Nebbi district health centres
Arua and Nebbi District, Uganda