NCT01067443

Brief Summary

This study is to assess if shorter combinations of SSG plus single dose AmBisome®, Miltefosine plus single dose AmBisome® and Miltefosine alone are effective in treating visceral leishmaniasis in Eastern Africa.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
151

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2010

Shorter than P25 for phase_2

Geographic Reach
2 countries

3 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

First Submitted

Initial submission to the registry

February 10, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 11, 2010

Completed
18 days until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

April 24, 2017

Status Verified

April 1, 2017

Enrollment Period

1.3 years

First QC Date

February 10, 2010

Last Update Submit

April 21, 2017

Conditions

Primary Visceral Leishmaniasis

Keywords

Phase IIRandomised clinical trialVisceral Leishmaniasis

Outcome Measures

Primary Outcomes (1)

  • Initial cure: proportion cured at Day 28

    Day 28

Secondary Outcomes (2)

  • Final cure: proportion cured at day 210

    6 months post treatment

  • Adverse events and serious adverse events occurring in the three study arms

    up to day 60

Study Arms (3)

Amb+SSG

EXPERIMENTAL

AmBisome® one dose of 10mg/kg body weight (IV) on day 1 followed by 10 days of SSG at 20mg/kg body weight (IV/IM) from days 2-11

Drug: Liposomal amphotericin B (AmBisome®) and sodium stibogluconate

Amb+Milt

EXPERIMENTAL

AmBisome® one dose of 10mg/kg body weight (IV) on day 1 followed by 10 days Miltefosine at 2.5mg/kg body weight (oral) from days 2-11

Drug: Liposomal amphotericin B + miltefosine

Milt

EXPERIMENTAL

Monotherapy course of Miltefosine at 2.5mg/kg body weight (oral) from days 1-28

Drug: Miltefosine

Interventions

Liposomal amphotericin B (AmBisome®) and sodium stibogluconateDRUG

AmBisome® one dose of 10mg/kg body weight (IV) on day 1 followed by 10 days of SSG at 20mg/kg body weight (IV/IM) from days 2-11

Amb+SSG
Liposomal amphotericin B + miltefosineDRUG

AmBisome® one dose of 10mg/kg body weight (IV) on day 1 followed by 10 days Miltefosine at 2.5mg/kg body weight (oral) from days 2-11

Amb+Milt
MiltefosineDRUG

Monotherapy course of Miltefosine at 2.5mg/kg body weight (oral) from days 1-28

Milt

Eligibility Criteria

Age7 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients with clinical signs and symptoms of VL and diagnosis confirmed by visualization of parasites in tissue samples (lymph node, bone marrow or spleen where relevant) on microscopy.
  • Patients aged between 7 (to allow for blood sampling) and 60 years (inclusive) who are able to comply with the protocol.
  • Patients for whom written informed consent has been signed by the patients themselves (if aged 18 years and over) or by parents(s) or legal guardian for patients under 18 years of age.
  • HIV negative status

You may not qualify if:

  • Patients who have received any anti-leishmanial drugs in the last 6 months/ relapse cases.
  • Patients with a negative lymph node/bone marrow (or spleen) smears.
  • Patients with severe protein and or caloric malnutrition (Kwashiorkor or marasmus ; Adults: BMI \</= 15, Children W/H\<70, presence of oedema)
  • Patients with previous history of hypersensitivity reaction to SSG or Amphotericin B.
  • Patients suffering from a concomitant severe infection such as TB or any other serious underlying disease (cardiac, renal, hepatic) which would preclude evaluation of the patient's response to study medication.
  • Patients suffering from other conditions associated with splenomegaly such as schistosomiasis.
  • Patients with previous history of cardiac arrhythmia or an abnormal ECG
  • Patients who are female of child bearing age (all females who have achieved menarche) / pregnant or lactating.
  • Patients with haemoglobin \< 5gm/dl.
  • Patients with WBC \< 1 x 10³/mm³.
  • Patients with platelets \< 40,000/mm³.
  • Patients with abnormal liver function (ALT and AST) tests of more than three times the normal range.
  • Patients with serum creatinine outside the normal range for age and gender.
  • Major surgical intervention within 2 weeks prior to enrolment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Kimalel Health Centre

Kimalel, Kenya

Location

Kassab Hospital

Kassāb, Al Qaḑārif, Sudan

Location

El Hassan Centre for Tropical Medicine

Doka, Gedarif, Sudan

Location

Related Publications (3)

  • Wasunna M, Njenga S, Balasegaram M, Alexander N, Omollo R, Edwards T, Dorlo TP, Musa B, Ali MH, Elamin MY, Kirigi G, Juma R, Kip AE, Schoone GJ, Hailu A, Olobo J, Ellis S, Kimutai R, Wells S, Khalil EA, Strub Wourgaft N, Alves F, Musa A. Efficacy and Safety of AmBisome in Combination with Sodium Stibogluconate or Miltefosine and Miltefosine Monotherapy for African Visceral Leishmaniasis: Phase II Randomized Trial. PLoS Negl Trop Dis. 2016 Sep 14;10(9):e0004880. doi: 10.1371/journal.pntd.0004880. eCollection 2016 Sep.

    PMID: 27627654DERIVED

  • Allison A, Edwards T, Omollo R, Alves F, Magirr D, E Alexander ND. Generalizing boundaries for triangular designs, and efficacy estimation at extended follow-ups. Trials. 2015 Nov 16;16:522. doi: 10.1186/s13063-015-1018-1.

    PMID: 26573827DERIVED

  • Omollo R, Alexander N, Edwards T, Khalil EA, Younis BM, Abuzaid AA, Wasunna M, Njoroge N, Kinoti D, Kirigi G, Dorlo TP, Ellis S, Balasegaram M, Musa AM. Safety and efficacy of miltefosine alone and in combination with sodium stibogluconate and liposomal amphotericin B for the treatment of primary visceral leishmaniasis in East Africa: study protocol for a randomized controlled trial. Trials. 2011 Jun 30;12:166. doi: 10.1186/1745-6215-12-166.

    PMID: 21718522DERIVED

MeSH Terms

Conditions

Leishmaniasis, Visceral

Interventions

liposomal amphotericin BAntimony Sodium Gluconatemiltefosine

Condition Hierarchy (Ancestors)

LeishmaniasisEuglenozoa InfectionsProtozoan InfectionsParasitic DiseasesInfectionsVector Borne Diseases

Intervention Hierarchy (Ancestors)

Organic ChemicalsGluconatesSugar AcidsAcids, AcyclicCarboxylic AcidsHydroxy AcidsCarbohydrates

Study Officials

  • Monique Wasunna, MD

    Kenya Medical Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2010

First Posted

February 11, 2010

Study Start

March 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

April 24, 2017

Record last verified: 2017-04

Locations

SU(2)KE(1)