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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Visceral Leishmaniasis

Intervention / Treatment
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* Drug: Paromomycin sulfate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Paromomycin IM Injection (approved product in India) | Drug: Paromomycin sulfate<br>* Paromomycin will be administered intramuscularly at 11 mg/kg, once a day, for 21 consecutive days<br>* Other names: Paromomycin IM Injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| M1: Safety as measured by adverse events, serious adverse events, vital signs, and laboratory parameters. |  | M1: Approximately 6 months | 
| M2&3: Program effectiveness as measured by specific criteria for healthcare workers, patients, and operational systems. |  | approximately 2.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| M2 and M3: Clinical cure as measured by temperature/hx of fever, spleen size decrease, and clinical assessment of treating physician. |  | approximately 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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visceral leishmaniasis, kala-azar, Bihar, India