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

Visceral Leishmaniasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00604955
• Other study ID #: VLPM03
• Status: Completed
• Phase: Phase 4
• First received: January 17, 2008
• Last updated: October 2, 2014
• Start date: October 2007
• Est. completion date: January 2010

Study information

• Verified date: October 2014
• Source: PATH
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: January 2010
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 55 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leishmaniasis
• Leishmaniasis, Visceral
• Visceral Leishmaniasis

Intervention

Drug:
• Paromomycin sulfate
Paromomycin will be administered intramuscularly at 11 mg/kg, once a day, for 21 consecutive days

Locations

Country	Name	City	State
India	Rajendra Memorial Research Institute of Medical Sciences	Agam Kuan, Patna	Bihar
India	Shrimati Hazari Maternity and Medical Care	Azad Nagar, Balua Tal, Motihari	Bihar
India	Research Centre for Diabetes, Hypertension and Obesity	Bengali Tola, Samastipur	Bihar
India	Kalazar Research Centre	Brahmpura	Muzaffarpur, Bihar
India	Dr. A.K. Aditya Clinic	East of Bhola Talkies, Samastipur	Bihar
India	Kala-zar Research Centre	Patna	Bihar
India	Kala-azar Medical Research Centre	Rambagh Road, Muzaffarpur	Bihar

Sponsors (1)

Lead Sponsor	Collaborator
PATH

Country where clinical trial is conducted

India, 

References & Publications (1)

Sundar S, Jha TK, Thakur CP, Sinha PK, Bhattacharya SK. Injectable paromomycin for Visceral leishmaniasis in India. N Engl J Med. 2007 Jun 21;356(25):2571-81. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	M1: Safety as measured by adverse events, serious adverse events, vital signs, and laboratory parameters.		M1: Approximately 6 months	Yes
Primary	M2&3: Program effectiveness as measured by specific criteria for healthcare workers, patients, and operational systems.		approximately 2.5 years	No
Secondary	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.		M1: Approximately 6 months	No
Secondary	M2 and M3: Clinical cure as measured by temperature/hx of fever, spleen size decrease, and clinical assessment of treating physician.		approximately 6 months	No