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

Information source: PATH
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Visceral Leishmaniasis

Intervention: Paromomycin sulfate (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: PATH

Official(s) and/or principal investigator(s):
P K Sinha, MD, Principal Investigator, Affiliation: Rajendra Memorial Research Institute of Medical Sciences
T K Jha, MD, Principal Investigator, Affiliation: Kalazar Research Centre
C P Thakur, MD, Principal Investigator, Affiliation: Kala-azar Research Centre
Shyam Sundar, MD, Principal Investigator, Affiliation: Kala-azar Medical Research Centre
Devendra Nath, MD, Principal Investigator, Affiliation: Shrimati Hazari Maternity and Medical Care
Supriyo Mukherjee, MD, Principal Investigator, Affiliation: Research Centre for Diabetes, Hypertension and Obesity
Amrendra K Aditya, MD, Principal Investigator, Affiliation: Dr. A.K. Aditya Clinic

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.

Clinical Details

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

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

Primary outcome:

M1: Safety as measured by adverse events, serious adverse events, vital signs, and laboratory parameters.

M2&3: Program effectiveness as measured by specific criteria for healthcare workers, patients, and operational systems.

Secondary outcome:

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.

M2 and M3: Clinical cure as measured by temperature/hx of fever, spleen size decrease, and clinical assessment of treating physician.

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

Minimum age: 2 Years. Maximum age: 55 Years. Gender(s): Both.

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.

Locations and Contacts

Rajendra Memorial Research Institute of Medical Sciences, Agam Kuan, Patna, Bihar 800 007, India

Shrimati Hazari Maternity and Medical Care, Azad Nagar, Balua Tal, Motihari, Bihar 845 401, India

Research Centre for Diabetes, Hypertension and Obesity, Bengali Tola, Samastipur, Bihar 848 101, India

Dr. A.K. Aditya Clinic, East of Bhola Talkies, Samastipur, Bihar 848 101, India

Kala-zar Research Centre, Patna, Bihar 800 001, India

Kala-azar Medical Research Centre, Rambagh Road, Muzaffarpur, Bihar 842 001, India

Kalazar Research Centre, Brahmpura, Muzaffarpur, Bihar 842 003, India

Additional Information

Related publications:

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.

Starting date: October 2007
Last updated: October 2, 2014

Page last updated: August 23, 2015

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