Expand Access/Assess Safety and Efficacy of Paromomycin IM Injection for the Treatment of Visceral Leishmaniasis

This study has been completed.
Sponsor:
Information provided by:
PATH
ClinicalTrials.gov Identifier:
NCT00604955
First received: January 17, 2008
Last updated: April 7, 2011
Last verified: April 2011
  Purpose

This modular Program will first confirm the safety and efficacy of Paromomycin IM Injection when given to an expanded population in the outpatient setting in experienced VL centers and subsequently evaluate the effectiveness of an expanded access model of providing Paromomycin IM Injection to progressively more resource-constrained clinics in Bihar, India.


Condition Intervention Phase
Visceral Leishmaniasis
Drug: Paromomycin sulfate
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 4 Study to Expand Access Program While Assessing the Safety and Efficacy of Paromomycin IM Injection in an Outpatient Setting for the Treatment of Visceral Leishmaniasis

Resource links provided by NLM:


Further study details as provided by PATH:

Primary Outcome Measures:
  • M1: Safety as measured by adverse events, serious adverse events, vital signs, and laboratory parameters. [ Time Frame: M1: Approximately 6 months ] [ Designated as safety issue: Yes ]
  • M2&3: Program effectiveness as measured by specific criteria for healthcare workers, patients, and operational systems. [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • M1: Clinical cure as measured by temperature/hx of fever, spleen size decrease by at least 33% from baseline, and clinical assessment of treating physician. [ Time Frame: M1: Approximately 6 months ]
  • M2 and M3: Clinical cure as measured by temperature/hx of fever, spleen size decrease, and clinical assessment of treating physician. [ Time Frame: approximately 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 2000
Study Start Date: October 2007
Study Completion Date: January 2010
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Paromomycin IM Injection (approved product in India)
Drug: Paromomycin sulfate
Paromomycin will be administered intramuscularly at 11 mg/kg, once a day, for 21 consecutive days
Other Name: Paromomycin IM Injection

Detailed Description:

Safe, effective, and affordable treatments for visceral leishmaniasis (VL) that are widely available to the poorest population of rural India where the disease is endemic are urgently needed. Resistance to antimonials, which have historically been the first line of treatment for VL in Bihar and adjoining states, is a major problem. Other available treatments are limited by their high cost, toxicity, or contraindications in certain populations. Paromomycin IM Injection was approved for the treatment of VL in August 2006 by the Drug Controller General of India (DCGI).

The study is designed to establish a Phase 4 Access Program in a modular, stepwise fashion (Modules 1 to 3). The study will first confirm the safety and efficacy of Paromomycin IM Injection in an expanded VL population treated as an outpatient in experienced centers (Module 1); and then progressively extend the network of treatment facilities, the number and reach of the trained staff, and the implementation of the requisite logistics systems to rural Bihar (Modules 2 and 3). An expanded network of healthcare workers will be trained and supervised to make a preliminary diagnosis of VL; to make appropriate referrals to confirm the diagnosis of VL; to treat with Paromomycin IM Injection; and to assess patient safety and clinical response on an outpatient basis.

  Eligibility

Ages Eligible for Study:   2 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed, newly diagnosed or relapsed visceral leishmaniasis

Exclusion Criteria:

  • HIV infection, tuberculosis
  • Significant hematologic, renal or liver dysfunction
  • Malaria
  • Those unable to be treated as an outpatient.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00604955

Locations
India
Rajendra Memorial Research Institute of Medical Sciences
Agam Kuan, Patna, Bihar, India, 800 007
Shrimati Hazari Maternity and Medical Care
Azad Nagar, Balua Tal, Motihari, Bihar, India, 845 401
Kala-zar Research Centre
Balaji Utthan Sanastan, Fraser Road "Uma Complex", Patna, Bihar, India, 800 001
Research Centre for Diabetes, Hypertension and Obesity
Bengali Tola, Samastipur, Bihar, India, 848 101
Dr. A.K. Aditya Clinic
East of Bhola Talkies, Samastipur, Bihar, India, 848 101
Kala-azar Medical Research Centre
Rambagh Road, Muzaffarpur, Bihar, India, 842 001
Kalazar Research Centre
Brahmpura, Muzaffarpur, Bihar, India, 842 003
Sponsors and Collaborators
PATH
Investigators
Principal Investigator: P K Sinha, MD Rajendra Memorial Research Institute of Medical Sciences
Principal Investigator: T K Jha, MD Kalazar Research Centre
Principal Investigator: C P Thakur, MD Kala-azar Research Centre
Principal Investigator: Shyam Sundar, MD Kala-azar Medical Research Centre
Principal Investigator: Devendra Nath, MD Shrimati Hazari Maternity and Medical Care
Principal Investigator: Supriyo Mukherjee, MD Research Centre for Diabetes, Hypertension and Obesity
Principal Investigator: Amrendra K Aditya, MD Dr. A.K. Aditya Clinic
  More Information

Publications:
Responsible Party: Kelly Oliver, Institute for OneWorld Health
ClinicalTrials.gov Identifier: NCT00604955     History of Changes
Other Study ID Numbers: VLPM03
Study First Received: January 17, 2008
Last Updated: April 7, 2011
Health Authority: India: Ministry of Health

Keywords provided by PATH:
visceral leishmaniasis
kala-azar
Bihar, India

Additional relevant MeSH terms:
Leishmaniasis
Leishmaniasis, Visceral
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Paromomycin
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on July 22, 2014