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

NCT01328457 | Completed DMC

• 1 other identifier: VLPMIM402
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

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).

Conditions

Visceral Leishmaniasis

Keywords

Leishmaniasis, Visceral; kala-azar; Paromomycin; Bangladesh; Injections, Intramuscular; Treatment Outcome; Patient compliance; Medication adherence; Drug toxicity

Outcome Measures

Primary Outcomes (1)

• Final cure rate

  Criteria evaluated (binary fashion): 1. Patient's temperature less than 99.4°F in clinic at EOT visit? (Y/N) 2. Patient reported resolution of fever and NO fever within the last 5 days? (Y/N) 3. Spleen size decreased from screening value? (Y/N) 4. Is the clinical impression of the treating physician that of an adequate clinical response? (Y/N) The patient is deemed to have achieved final cure if answers to a, b, c, AND d are all "Yes" OR if one answer (a, b, or c) is "No" but all others and "d" are "Yes". In addition, the clinician will inquire about pregnancy status for female patients.

  6 months after end of treatment (Day 202/203, -15 to +30 days)

Secondary Outcomes (4)

• Initial clinical response rate

  End of treatment (21/22 days after treatment begins)

• Patient compliance with PMIM treatment

  22 days

• Safety of PMIM in the study population based on clinical assessment by the study physician at the Upazilla Health Centre.

  6 months after end of treatment

• To introduce PMIM in government health facilities in rural Bangladesh.

  October 2011

Interventions

Paromomycin sulfate DRUG

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).

Also known as: 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

• Age: 5 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• VL serologically confirmed using the rK39 test:
• Willingness / ability to understand and provide informed consent prior to participation in this study:
• Age ≥ five years and ≤ 55 years, and weighing at least five kg
• Adequately hydrated as assessed by clinical criteria and able to maintain adequate hydration on an outpatient basis through oral intake of fluids
• 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)
• Living in the VL-endemic areas in Bangladesh

You may not qualify if:

• Active tuberculosis or taking anti-tuberculosis medications
• Previous treatment with Paromomycin IM Injection (PMIM)
• Clinically significant severe anemia as determined by the investigator
• Clinically significant renal or hepatic dysfunction as determined by the investigator, or history of clinically significant renal or hepatic dysfunction
• History of Hepatitis B or C; or known HIV positive
• History of hearing loss
• 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
• Major surgery within 30 days prior to first dose of PMIM
• History of hypersensitivity to aminoglycosides or to any of the components of PMIM, including sulfite
• Any history of VL or treatment of VL at any time
• Patients who have received any investigational (unlicensed) drug within the last six months
• Concomitant use of other aminoglycosides (e.g., gentamicin, tobramycin, amikacin), nephrotoxic and ototoxic drugs, or immunosuppressive drugs
• Proteinuria (results \> 1+ ) on urine dipstick analysis at screening visit and/or
• Serum creatinine above the upper limit of normal (ie, serum creatinine \>1.1 mg/dl in males and \>0.9 mg/dl in females
• Pregnant or lactating women

Sponsors & Collaborators

• PATH: lead
• International Centre for Diarrhoeal Disease Research, Bangladesh: collaborator
• Shaheed Suhrawardy Medical College Hospital, Dhaka, Bangladesh: collaborator
• GVK Biosciences: collaborator

Study Sites (3)

Bhaluka Upazila Health Complex

Bhaluka, Mymensingh District, Bangladesh

Location

Trishal Upazila Health Complex

Trishal, Mymensingh District, Bangladesh

Location

Icddr,B

Dhaka, Bangladesh

Location

Related Publications (3)

• 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.

  PMID: 17582067 BACKGROUND

• 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.

  PMID: 9145856 BACKGROUND

• 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.

  PMID: 26496648 DERIVED

MeSH Terms

Conditions

Leishmaniasis, Visceral; Patient Compliance; Medication Adherence; Drug-Related Side Effects and Adverse Reactions

Interventions

Paromomycin

Condition Hierarchy (Ancestors)

Leishmaniasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Vector Borne Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Rashidul Haque, MB, PhD

  International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2011
• First Posted: April 4, 2011
• Study Start: January 1, 2011
• Primary Completion: May 1, 2011
• Study Completion: June 1, 2012
• Last Updated: April 4, 2014

Record last verified: 2012-08

Locations

BA (3)