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 @ 10:57 PM
Ignite Modification Date:
2025-12-24 @ 10:57 PM
NCT ID:
NCT00696969
Eligibility Criteria:
Inclusion Criteria:
* Adults ( male or female) 18-60 years of age
* Acute, symptomatic, non-severe (minimum Hb.5 gm/dL) VL proven by parasitological examination of splenic or bone marrow aspirate.
* History of fever.
* Living within reachable distance of the trial site to enable attendance for follow-up visits
* Written informed consent to participate
* Proven HIV negative status
* Women of child-bearing potential who are using an assured method of contraception
Exclusion Criteria:
* Signs/symptoms indicative of severe VL ( Hb.\< 5gm/dl, evidence of cardiac failure, etc)
* Patients who have received anti-leishmanial or anti-fungal treatment within the last 45 days
* Patients who have received any investigational (unlicensed) drugs within the last 6 months
* Severe malnutrition BMI\<15 in adults, weight for height less than 60% in children.
* Chronic underlying disease such as severe cardiac, renal, or hepatic impairment.
* Renal function tests (serum creatinine) outside the normal range
* Liver function tests (transaminases) more than three times the upper limit of the normal range at study entry
* Jaundice (bilirubin \>2.0mg/dL)
* Known hepatitis B or C positive
* Platelet count less than 40,000/mm3
* Prothrombin time 5 seconds or greater than normal range
* TotalWBC \< 1,000/mm3
* Known alcohol or other drug abuse
* HIV positive status
* Pregnancy and/or lactation
* Females having unprotected sexual intercourse, or using a non-assured method of contraception (e.g. condom)
* Concomitant chronic drug treatment eg for diabetes, hypertension, TB, HIV etc
* Concomitant drug usage for acute infection, eg malaria, pneumonia etc within the last 7 days
* Any other condition which may invalidate the trial
* Known hypersensitivity to AmBisome, Paromomycin, amphotericin B and/or Miltefosine
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00696969
Study Brief:
Protocol Section:
NCT00696969