Treatment and Diagnosis of Plague

NCT00128466 | Completed Phase 2 DMC

• 1 other identifier: CDC-NCID-3700
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial will compare the effectiveness of streptomycin, which historically is the standard drug for treatment of plague, with gentamicin. The hypothesis is that gentamicin is not inferior to streptomycin but that it will have less severe side effects. The study is being done in Madagascar because that country reports the most plague cases in the world. Patients coming into a participating clinic with suspected plague (bubonic, pneumonic, or septicemic) will be randomized into one of two treatment arms after giving informed consent. Patients will be monitored for side effects and for improvement of symptoms. In addition, rapid diagnostic test strips have been developed but not fully evaluated for use on humans. The investigators will evaluate these new tests on specimens from the same patients, comparing their performance with that of classical diagnostic methods such as culture and serology.

Conditions

Plague

Keywords

bubonic plague; pneumonic plague; septicemic plague; Yersinia pestis; Pasteurella pestis

Outcome Measures

Primary Outcomes (1)

• Survival or death at 2 weeks

Secondary Outcomes (3)

• Time to defervescence during treatment

• Number and severity of adverse effects at 2 weeks

• Complications at 2 weeks

Interventions

gentamicin DRUG

streptomycin DRUG

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older.
• Patients must have had potential exposure to rodents and/or their fleas or contact with a known plague case.
• Patients must have a fever of at least 38 °C that developed rapidly, and have one of the following:
• One or more buboes (defined as tender lymph node swelling \>=1 cm) that appeared after or at the same time as the fever; or
• Clinical suspicion of pneumonic plague (prostration, cough, increased respiratory rate, hemoptysis and/or purulent sputum); or
• Clinical suspicion of plague AND an epidemiological link with other cases.
• Only patients that are later confirmed by standard diagnostic tests will be included in the final analysis. Patients who do not have plague confirmed by standard tests will still be included in the safety analysis.

You may not qualify if:

• Has signs fitting plague meningitis (severely ill patient with signs of plague and one or more of the following: headache, fever, sensorial disturbances, neck and back stiffness, and/or positive Kernig and Brudzinski signs).
• Has hypotension unresponsive to fluid therapy (i.e. shock). In adults hypotension is defined as systolic blood pressure \< 80 mmHg and heart rate \> 110/min; in children it will need to be diagnosed by attending physician or medical officer.
• Has an "illness severity score" of 16 or higher (see Patient Record)
• Has a known allergy to gentamicin, streptomycin, or trimethoprim-sulfamethoxazole
• Is receiving dialysis for renal failure
• Has other severe underlying disease such as hepatic failure or other severe organ failure
• Has taken tetracyclines, quinolones, gentamicin, streptomycin, trimethoprim-sulfamethoxazole, or chloramphenicol in the last 24 hours. If the patient has taken medications that are not known, he/she will still be enrolled.

Sponsors & Collaborators

• Centers for Disease Control and Prevention: lead
• Food and Drug Administration (FDA): collaborator
• Ministry of Health, Madagascar: collaborator
• Ministry of Health, Uganda: collaborator

Study Sites (1)

Ministry of Health

Antananarivo, Antananarivo, Madagascar

Location

MeSH Terms

Conditions

Plague

Interventions

Gentamicins; Streptomycin

Condition Hierarchy (Ancestors)

Yersinia Infections; Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Kevin Griffith, MD, MPH

  Centers for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

• Martin Schriefer, PhD

  Centers for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED

Study Record Dates

• First Submitted: August 9, 2005
• First Posted: August 10, 2005
• Study Start: August 1, 2004
• Study Completion: February 1, 2007
• Last Updated: February 26, 2009

Record last verified: 2009-02

Locations

MA (1)