An Effectiveness Study of Paromomycin IM Injection (PMIM) for the Treatment of Visceral Leishmaniasis (VL) in Bangladesh

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effectiveness of treatment with PMIM in patients with visceral leishmaniasis within the VL-endemic region of Bangladesh at EOT (21/22 days after treatment begins), and at 6 months after end of treatment (Day 202/203, -15 to +30 days).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PATH
• Collaborators: GVK Biosciences; GVK Biosciences Private Limited, Gurgaon, India; International Centre for Diarrhoeal Disease Research, Bangladesh; Shaheed Suhrawardy Medical College Hospital, Dhaka, Bangladesh
• Treatments: Neomycin; Paromomycin

Criteria

Inclusion Criteria:

1. Signs and symptoms of VL including:

• History of intermittent fever for at least two weeks

• History of weight loss and/or decrease in appetite

• Enlarged spleen

2. VL serologically confirmed using the rK39 test:

3. Willingness / ability to understand and provide informed consent prior to participation in this study:

4. Age ≥ five years and ≤ 55 years, and weighing at least five kg

5. Adequately hydrated as assessed by clinical criteria and able to maintain adequate hydration on an outpatient basis through oral intake of fluids

6. Clinically stable and appropriate for treatment with PMIM as an outpatient, if possible (subjects may be hospitalized to receive 21-day dosing at the discretion of the investigator)

7. Living in the VL-endemic areas in Bangladesh

Exclusion Criteria:

1. Active tuberculosis or taking anti-tuberculosis medications

2. Previous treatment with Paromomycin IM Injection (PMIM)

3. Clinically significant severe anemia as determined by the investigator

4. Clinically significant renal or hepatic dysfunction as determined by the investigator, or history of clinically significant renal or hepatic dysfunction

5. History of Hepatitis B or C; or known HIV positive

6. History of hearing loss

7. Other serious illness or medical condition that, in the opinion of the doctor, would interfere with the patient's ability to receive PMIM treatment or comply with the study procedures, or that could obscure toxicity of or response to PMIM

8. Major surgery within 30 days prior to first dose of PMIM

9. History of hypersensitivity to aminoglycosides or to any of the components of PMIM, including sulfite

10. Any history of VL or treatment of VL at any time

11. Patients who have received any investigational (unlicensed) drug within the last six months

12. Concomitant use of other aminoglycosides (e.g., gentamicin, tobramycin, amikacin), nephrotoxic and ototoxic drugs, or immunosuppressive drugs

13. Proteinuria (results > 1+ ) on urine dipstick analysis at screening visit and/or

14. Serum creatinine above the upper limit of normal (ie, serum creatinine >1.1 mg/dl in males and >0.9 mg/dl in females

15. Pregnant or lactating women