Efficacy/Safety of Sodium Stibogluconate (SSG) Versus Paromomycin (PM) and SSG/PM Combination to Treat V Leishmaniasis

NCT00255567 | Completed Phase 3 DMC

• 1 other identifier: DNDi-LEAP0104
• Study Type: interventional
• Target: 1,142
• Locations: 4 countries
• Sites: 5

Brief Summary

The purpose of this study is to assess the efficacy and safety of SSG 30 days alone, PM 21 days alone and SSG and PM as a combination course of 17 days in the treatment of patients with VL.

Conditions

Visceral Leishmaniasis

Keywords

Visceral Leishmaniasis; Combination

Outcome Measures

Primary Outcomes (1)

• parasitological clearance at 6 months post treatment by splenic, lymph node, or bone marrow smear.

  6 months post treatment

Study Arms (3)

1

ACTIVE COMPARATOR

Sodium Stibogluconate (30 days)

Drug: Sodium Stibogluconate

2

EXPERIMENTAL

Paromomycin Sulphate (21 days)

Drug: Paromomycin sulphate

3

EXPERIMENTAL

Sodium Stibogluconate + Paromomycin Sulphate (17 days)

Drug: SSG and Paromomycin sulphate

Interventions

Sodium Stibogluconate DRUG

Sodium Stibogluconate 20mg/kg/day for 30 days

1

Paromomycin sulphate DRUG

Paromomycin sulphate

2

SSG and Paromomycin sulphate DRUG

SSG and Paromomycin Sulphate 17 days

3

Eligibility Criteria

• Age: 4 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• Patients aged between 4 and 60 years (inclusive) who are able to comply with the protocol. It is justified to include children because they represent more than 50% of VL cases.
• Patients with clinical signs and symptoms of VL and diagnosis confirmed by visualization of parasites in tissue samples (spleen, lymph node or bone marrow) on microscopy.

You may not qualify if:

• Patients who have received any anti-leishmanial drug in the last 6 months.
• Patients with a negative splenic / lymph node / bone marrow smears.
• Patients with a clinical contraindication to splenic/lymph node/ bone marrow aspirates.
• Patients with severe protein and or caloric malnutrition (Kwashiokor or marasmus)
• Patients with previous hypersensitivity reaction to SSG or aminoglycosides.
• 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 patients 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 pregnant or lactating.
• Patients with haemoglobin \< 5gm/dl.
• Patients with WBC \< 1 x 10³/mm³.
• Patients with platelets \< 40,000/mm³.
• Patients with liver function tests more than three times the normal range
• Patients with serum creatinine outside the normal range for age and gender
• Patients with pre-existing clinical hearing loss.

Sponsors & Collaborators

• Drugs for Neglected Diseases: lead

Study Sites (5)

Arba Minch Hospital

Arba Minch, Ethiopia

Location

Gondar hospital

Gonder, Ethiopia

Location

KEMRI

Nairobi, Kenya

Location

Kassab Hospital

Kassāb, Sudan

Location

Amudat Hospital

Amudat, Nakipiripirit District, Uganda

Location

Related Publications (2)

• Musa A, Khalil E, Hailu A, Olobo J, Balasegaram M, Omollo R, Edwards T, Rashid J, Mbui J, Musa B, Abuzaid AA, Ahmed O, Fadlalla A, El-Hassan A, Mueller M, Mucee G, Njoroge S, Manduku V, Mutuma G, Apadet L, Lodenyo H, Mutea D, Kirigi G, Yifru S, Mengistu G, Hurissa Z, Hailu W, Weldegebreal T, Tafes H, Mekonnen Y, Makonnen E, Ndegwa S, Sagaki P, Kimutai R, Kesusu J, Owiti R, Ellis S, Wasunna M. Sodium stibogluconate (SSG) & paromomycin combination compared to SSG for visceral leishmaniasis in East Africa: a randomised controlled trial. PLoS Negl Trop Dis. 2012;6(6):e1674. doi: 10.1371/journal.pntd.0001674. Epub 2012 Jun 19.

  PMID: 22724029 DERIVED

• Musa AM, Younis B, Fadlalla A, Royce C, Balasegaram M, Wasunna M, Hailu A, Edwards T, Omollo R, Mudawi M, Kokwaro G, El-Hassan A, Khalil E. Paromomycin for the treatment of visceral leishmaniasis in Sudan: a randomized, open-label, dose-finding study. PLoS Negl Trop Dis. 2010 Oct 26;4(10):e855. doi: 10.1371/journal.pntd.0000855.

  PMID: 21049063 DERIVED

MeSH Terms

Conditions

Leishmaniasis, Visceral

Interventions

Antimony Sodium Gluconate; Paromomycin

Condition Hierarchy (Ancestors)

Leishmaniasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Organic Chemicals; Gluconates; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Hydroxy Acids; Carbohydrates; Aminoglycosides; Glycosides

Study Officials

• Manica Balasegaram

  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
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2005
• First Posted: November 21, 2005
• Study Start: November 1, 2004
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: March 22, 2016

Record last verified: 2016-03

Locations

ET (2); SU (1); KE (1); UG (1)