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

NCT ID: NCT01328457

Last Updated: 2014-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2012-06-30

Brief 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).

Detailed Description

Safe, effective and affordable treatments for visceral leishmaniasis (VL) that are widely available to the poorest populations are urgently needed in Bangladesh in areas where the disease is endemic. Paromomycin IM Injection (PMIM) was approved for the treatment of VL in August 2006 by the Drugs Controller General of India (DCGI), and it offers an attractive alternative to treatments that are currently available.

Conditions

Visceral Leishmaniasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Paromomycin sulfate

Paromomycin IM Injection, 11 mg/kg as the base, intramuscular, once a day on 21 consecutive days (or no more than 22 days if one injection is missed during the treatment period).

Intervention Type: DRUG

Other Intervention Names

aminosidin sulfate; aminosidine sulfate; monomycin A sulfate; amminosidin sulfate; catenulin sulfate; crestomycin sulfate; estomycin sulfate; hydroxymycin sulfate; neomycin E sulfate; paucimycin sulfate; Humatin®; Gabbromicina®; Gabromicina®; Gabromycin®; Gabboral®; Kapseal®; Pargonyl

Eligibility 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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

International Centre for Diarrhoeal Disease Research, Bangladesh

OTHER

Sponsor Role: collaborator

Shaheed Suhrawardy Medical College Hospital, Dhaka, Bangladesh

UNKNOWN

Sponsor Role: collaborator

GVK Biosciences

OTHER

Sponsor Role: collaborator

PATH

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rashidul Haque, MB, PhD

Role: PRINCIPAL_INVESTIGATOR

International Centre for Diarrhoeal Disease Research, Bangladesh

Locations

Bhaluka Upazila Health Complex

Bhaluka, Mymensingh District, Bangladesh

Trishal Upazila Health Complex

Trishal, Mymensingh District, Bangladesh

Icddr,B

Dhaka, , Bangladesh

Countries

Bangladesh

References

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.

Reference Type: BACKGROUND

PMID: 17582067 (View on PubMed)

Kanyok TP, Killian AD, Rodvold KA, Danziger LH. Pharmacokinetics of intramuscularly administered aminosidine in healthy subjects. Antimicrob Agents Chemother. 1997 May;41(5):982-6. doi: 10.1128/AAC.41.5.982.

Reference Type: BACKGROUND

PMID: 9145856 (View on PubMed)

Jamil KM, Haque R, Rahman R, Faiz MA, Bhuiyan AT, Kumar A, Hassan SM, Kelly H, Dhalaria P, Kochhar S, Desjeux P, Bhuiyan MA, Khan MM, Ghosh RS. Effectiveness Study of Paromomycin IM Injection (PMIM) for the Treatment of Visceral Leishmaniasis (VL) in Bangladesh. PLoS Negl Trop Dis. 2015 Oct 23;9(10):e0004118. doi: 10.1371/journal.pntd.0004118. eCollection 2015.

Reference Type: DERIVED

PMID: 26496648 (View on PubMed)

Other Identifiers

VLPMIM402

Identifier Type: -

Identifier Source: org_study_id