Clinical trial NCT00604955: Expand Access/Assess Safety and Efficacy of Paromomycin IM Injection for the Treatment of Visceral Leishmaniasis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Visceral Leishmaniasis
Keywords: visceral leishmaniasis
kala-azar
Bihar, India
Lead sponsor: PATH
Sponsor class: OTHER
First posted: 2008-01-30
Enrollment: 2000
Sex: ALL
Minimum age (years): 2
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: M1: Safety as measured by adverse events, serious adverse events, vital signs, and laboratory parameters.
timeFrame: M1: Approximately 6 months
measure: M2&3: Program effectiveness as measured by specific criteria for healthcare workers, patients, and operational systems.
timeFrame: approximately 2.5 years
Secondary outcomes:
measure: 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.
timeFrame: M1: Approximately 6 months
measure: M2 and M3: Clinical cure as measured by temperature/hx of fever, spleen size decrease, and clinical assessment of treating physician.
timeFrame: approximately 6 months
Other outcomes:
Locations:
city: Agam Kuan, Patna
country: India
facility: Rajendra Memorial Research Institute of Medical Sciences
state: Bihar
city: Azad Nagar, Balua Tal, Motihari
country: India
facility: Shrimati Hazari Maternity and Medical Care
state: Bihar
city: Bengali Tola, Samastipur
country: India
facility: Research Centre for Diabetes, Hypertension and Obesity
state: Bihar
city: East of Bhola Talkies, Samastipur
country: India
facility: Dr. A.K. Aditya Clinic
state: Bihar
city: Patna
country: India
facility: Kala-zar Research Centre
state: Bihar
city: Rambagh Road, Muzaffarpur
country: India
facility: Kala-azar Medical Research Centre
state: Bihar
city: Brahmpura
country: India
facility: Kalazar Research Centre
state: Muzaffarpur, Bihar
Study officials:
affiliation: Rajendra Memorial Research Institute of Medical Sciences
name: P K Sinha, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kalazar Research Centre
name: T K Jha, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kala-azar Research Centre
name: C P Thakur, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kala-azar Medical Research Centre
name: Shyam Sundar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shrimati Hazari Maternity and Medical Care
name: Devendra Nath, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Research Centre for Diabetes, Hypertension and Obesity
name: Supriyo Mukherjee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dr. A.K. Aditya Clinic
name: Amrendra K Aditya, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1056/NEJMoa066536.