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:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT00657618
Eligibility Criteria:
Inclusion Criteria:
1. DoD healthcare beneficiary of any age and gender.
2. Clinicoepidemiologic or parasitologic diagnosis (microscopy, PCR or culture) of Leishmania infection.
3. Able to provide informed consent or assent (children).
4. All participants (both male and female) must agree to take precautions not to become pregnant or father a child for at least 2 months after receiving SSG.
Exclusion Criteria:
1. Pregnancy. Females of childbearing potential must have negative urine human chorionic gonadotropin hormone (HCG) within 96 hours start of infusion period.
2. History of hypersensitivity to pentavalent antimonials.
3. Any of the following on screening examination:
1. QTc interval greater or equal to 0.5 sec
2. Severe cardiac disease (disabling valvular heart disease, myopathy, or arrhythmias)
3. History of recurrent pancreatitis
4. Liver failure or active hepatitis with transaminases \> 3x upper limit of normal
5. Renal failure or creatinine \> 2.5 mg/dL
6. Thrombocytopenia (platelets \<100,000/mm\^3)
7. White blood cell count \< 2000 / mm\^3
8. Hematocrit \< 30 %
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00657618
Study Brief:
Protocol Section:
NCT00657618