Visceral Leishmaniasis Clinical Trial
Official title:
A Phase III, Open Label, Randomised, Study of Three Short Course Combination Regimens (Ambisome®, Miltefosine, Paromomycin) Compared With AmBisome® Alone for the Treatment of Visceral Leishmaniasis (VL) in Bangladesh
This protocol will evaluate the efficacy and safety of various combinations of the three drugs; AmBisome, Paromomycin and Miltefosine at reduced total dosage against the standard treatment with a total dose of 15mg/kg of AmBisome.
Status | Completed |
Enrollment | 602 |
Est. completion date | March 2014 |
Est. primary completion date | March 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 5 Years to 60 Years |
Eligibility |
Inclusion Criteria: - VL proven by parasitological examination of splenic or bone marrow aspirate. Parasite burden to be graded according to Chulay and Bryceson 1983 and subsequently adopted by WHO. (Step 1 only) - History of fever, for at least 2 weeks with one or more of the followings criteria: Anaemia (5<Hb<10g/dl), Loss of weight, Splenomegaly - rk39 positive at baseline assessments - willing and able to attend follow-up visits - Male or Female age: 5-60 yrs - Written informed consent from the patient or from patient's parent or guardian if the patient is under 18 yrs, in addition written assent from patients of 11 - 17 yrs of age. If the patient or parent/guardian are illiterate an impartial witness should be present during the consenting procedure and should also sign. Exclusion Criteria: - Married women of child-bearing potential (defined as women who have achieved menarche) who are not using an assured method of contraception or are unwilling to use an assured method of contraception for the duration of treatment and three months after. Assured methods of contraception include i.e. IUCD or depot hormone injection of medroxyprogesterone acetate MPA (DepoProvera®) - Platelet count less than 40,000/mm3 (Step 1 only) - Prothrombin time 5 seconds or greater than normal range (Step 1 only) - Known hepatitis B, C or known HIV positive - Patients who present with Para Kala-azar Dermal Leishmaniasis - Signs/symptoms indicative of severe VL (Hb < 5gm/dl, etc) - Patients with a previous history of VL - Patients who have received any investigational (unlicensed) drugs within the last 3 months - Severe malnutrition BMI<15 in adults, weight for height less than 60% in children - Clinical symptoms of chronic underlying disease such as severe cardiac, renal or hepatic impairment - Positive HRP2/pLDH Combo test for malaria - Pregnant woman or breast-feeding mother - Known alcohol or other drug abuse - Concomitant chronic drug treatment eg. TB, HIV etc. - Known hypersensitivity to AmBisome, Paromomycin and other aminoglycosides and/or Miltefosine |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Bangladesh | Bhaluka UZHC | Bhaluka | Mymensingh |
Bangladesh | Gaffargaon | Gaffargaon | Mymensingh |
Bangladesh | Community Based Medical College | Trishal | Mymensingh |
Bangladesh | Trishal UZHC | Trishal | Mymensingh |
Lead Sponsor | Collaborator |
---|---|
Drugs for Neglected Diseases | International Centre for Diarrhoeal Disease Research, Bangladesh, Shaheed Surhawardy Medical College and Hospital |
Bangladesh,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Definitive cure | The primary endpoint variable is definitive cure at month 6, and is defined as no significant clinical signs or symptoms of VL at Day 45 including lack of fever [axiliary temperature < 99.5°F] and at least one of the following: improved Hb if the patient was anaemic at baseline (Hb< 8g/dl) spleen regression if the spleen was palpable on admission and absence of clinical signs and symptoms of VL (fever, weight loss, splenomegaly) at any time during 6 months post treatment period. |
6 month post treatment | No |
Secondary | Initial Cure | Initial Cure is defined as no significant clinical signs or symptoms of VL at Day 45 ie lack of fever [axiliary temp < 99.5°F and at least one of the following: improved Hb if the patient was anaemic at baseline (Hb< 8g/dl) spleen regression if the spleen was palpable on admission |
Day 45 | No |
Secondary | Adverse events | Assess safety during treatment and follow-up in different healthcare settings in hospital setting based on clinical adverse events, laboratory parameters during treatment and 6 months follow-up In UZHC setting based on clinical adverse events, limited laboratory parameters during treatment and 6 months follow-up |
Treatment | Yes |
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