Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:43 PM
Ignite Modification Date:
2025-12-24 @ 4:43 PM
NCT ID:
NCT00128466
Eligibility Criteria:
Inclusion Criteria:
* 2 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.
Exclusion Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Study:
NCT00128466
Study Brief:
Protocol Section:
NCT00128466