- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01328457
An Effectiveness Study of Paromomycin IM Injection (PMIM) for the Treatment of Visceral Leishmaniasis (VL) in Bangladesh
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Dhaka, Bangladesh
- Icddr,b
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Mymensingh District
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Bhaluka, Mymensingh District, Bangladesh
- Bhaluka Upazila Health Complex
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Trishal, Mymensingh District, Bangladesh
- Trishal Upazila Health Complex
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Final cure rate
Time Frame: 6 months after end of treatment (Day 202/203, -15 to +30 days)
|
Criteria evaluated (binary fashion):
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Initial clinical response rate
Time Frame: End of treatment (21/22 days after treatment begins)
|
Criteria evaluated (binary fashion):
The patient is deemed to achieve an initial clinical response 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". Also, the clinician will inquire re: pregnancy status for female patients. |
End of treatment (21/22 days after treatment begins)
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Patient compliance with PMIM treatment
Time Frame: 22 days
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Proportion of patients complying with prescribed 21 daily injections over no more than 22 days.
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22 days
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Safety of PMIM in the study population based on clinical assessment by the study physician at the Upazilla Health Centre.
Time Frame: 6 months after end of treatment
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All serious adverse events (SAEs), regardless of causality, from time of first administration of PMIM through 30 days post-EOT. All adverse events (AEs), regardless of causality, from time of first dose through 30 days post-EOT. Vital signs on Study Days 1 to 21/22 (or early termination), any unscheduled visit after EOT, 30 days after EOT, and 6 months after EOT. Patients who become pregnant during treatment/within 30d following EOT will be included in the safety population. Offspring from pregnancies will be followed for safety under a separate study for a period up to 3 yrs after birth. |
6 months after end of treatment
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To introduce PMIM in government health facilities in rural Bangladesh.
Time Frame: October 2011
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Training study staff to provide treatment with PMIM at selected Upazila level health complexes in rural Bangladesh.
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October 2011
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Rashidul Haque, MB, PhD, International Centre for Diarrhoeal Disease Research, Bangladesh
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Infections
- Vector Borne Diseases
- Parasitic Diseases
- Protozoan Infections
- Skin Diseases, Parasitic
- Skin Diseases, Infectious
- Euglenozoa Infections
- Leishmaniasis
- Leishmaniasis, Visceral
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Anti-Bacterial Agents
- Protein Synthesis Inhibitors
- Antiprotozoal Agents
- Antiparasitic Agents
- Neomycin
- Paromomycin
Other Study ID Numbers
- VLPMIM402
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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