NCT00696969

Brief Summary

The overall objective of this trial is to identify a safe and effective combination, (coadministration) short course treatment for the treatment of visceral leishmaniasis which could be easily deployed in a control programme and will reduce the risk of parasite resistance occurring. Safety and tolerability should be such that the combination can be easily deployed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
634

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2008

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

June 11, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 13, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

February 11, 2010

Status Verified

February 1, 2010

Enrollment Period

1.6 years

First QC Date

June 11, 2008

Last Update Submit

February 10, 2010

Conditions

Visceral Leishmaniasis

Outcome Measures

Primary Outcomes (1)

  • Definitive cure based on parasitological clearance at Day 15 after start of combination therapy (Day 31 for standard therapy), no evidence of parasites at day 45 and no clinical signs or symptoms of VL at 6 months post treatment.

    6 months post treatment

Study Arms (4)

1

ACTIVE COMPARATOR
Drug: Amphotericin B Deoxycholate

2

EXPERIMENTAL
Drug: Ambisome + Miltefosine

3

EXPERIMENTAL
Drug: Ambisome and Paromomycin

4

EXPERIMENTAL
Drug: Miltefosine and Paromomycin

Interventions

Amphotericin B DeoxycholateDRUG

1 mg/kg e.o.d for 30 days

1
Ambisome + MiltefosineDRUG

Ambisome (i.v. single dose 5 mg/kg)+ Miltefosine 7 days

2
Ambisome and ParomomycinDRUG

Ambisome 5 mg/kg single dose + Paromomycin Sulphate 15mg/kg/day for 10 days

3
Miltefosine and ParomomycinDRUG

Miltefosine (standard dose) and Paromomycin Sulphate 15mg/kg/day for 10 days

4

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kala-azar medical centre

Muzaffarpur, Bihar, India

Location

Rajendra Memorial research Institute

Patna, Bihar, India

Location

Related Publications (1)

  • Sundar S, Sinha PK, Rai M, Verma DK, Nawin K, Alam S, Chakravarty J, Vaillant M, Verma N, Pandey K, Kumari P, Lal CS, Arora R, Sharma B, Ellis S, Strub-Wourgaft N, Balasegaram M, Olliaro P, Das P, Modabber F. Comparison of short-course multidrug treatment with standard therapy for visceral leishmaniasis in India: an open-label, non-inferiority, randomised controlled trial. Lancet. 2011 Feb 5;377(9764):477-86. doi: 10.1016/S0140-6736(10)62050-8. Epub 2011 Jan 20.

    PMID: 21255828DERIVED

MeSH Terms

Conditions

Leishmaniasis, Visceral

Interventions

amphotericin B, deoxycholate drug combinationliposomal amphotericin BmiltefosineParomomycin

Condition Hierarchy (Ancestors)

LeishmaniasisEuglenozoa InfectionsProtozoan InfectionsParasitic DiseasesInfectionsVector Borne Diseases

Intervention Hierarchy (Ancestors)

AminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Farrokh Modabber

    Drugs for Neglected Diseases

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 11, 2008

First Posted

June 13, 2008

Study Start

June 1, 2008

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

February 11, 2010

Record last verified: 2010-02

Locations

IN(2)