Clinical Trial: An Effectiveness Study of Paromomycin IM Injection (PMIM) for the Treatment of Visceral Leishmaniasis (VL) in Bangladesh
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: An Effectiveness Study of Paromomycin IM Injection (PMIM) for the Treatment of Visceral Leishmaniasis (VL) in Bangladesh
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 Summary: 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.
Sponsor: PATH
Current Primary Outcome: Final cure rate [ Time Frame: 6 months after end of treatment (Day 202/203, -15 to +30 days) ]
Criteria evaluated (binary fashion):
- Patient's temperature less than 99.4°F in clinic at EOT visit? (Y/N)
- Patient reported resolution of fever and NO fever within the last 5 days? (Y/N)
- Spleen size decreased from screening value? (Y/N)
- 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.
Original Primary Outcome: Final cure rate [ Time Frame: 6 months after end of treatment (Day 202/203, -15 to +30 days) ]
The following criteria will be evaluated in a binary fashion:
- Is the patient's temperature less than 99.4°F in clinic at EOT visit? (Y/N)
- Has the patient reported resolution of fever and NO fever within the last 5 days? (Y/N)
- Has spleen size decreased from screening value? (Y/N)
- 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".
Current Secondary Outcome:
- Initial clinical response rate [ Time Frame: End of treatment (21/22 days after treatment begins) ]
Criteria evaluated (binary fashion):
- Patient's temperature less than 99.4°F in clinic at EOT visit? (Y/N)
- Patient reported resolution of fever / NO fever within the last 5 days? (Y/N)
- Spleen size decreased from screening value? (Y/N)
- Is clinical impression of the treating physician that of an adequate clinical response? (Y/N)
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.
- Patient compliance with PMIM treatment [ Time Frame: 22 days ]Proportion of patients complying with prescribed 21 daily injections over no more than 22 days.
- 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 ]
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.
- To introduce PMIM in government health facilities in rural Bangladesh. [ Time Frame: October 2011 ]Training study staff to provide treatment with PMIM at selected Upazila level health complexes in rural Bangladesh.
Original Secondary Outcome:
- Initial clinical response rate [ Time Frame: End of treatment (21/22 days after treatment begins) ]
The following criteria will be evaluated in a binary fashion:
- Is the patient's temperature less than 99.4°F in clinic at EOT visit? (Y/N)
- Has the patient reported resolution of fever and NO fever within the last 5 days? (Y/N)
- Has spleen size decreased from screening value? (Y/N)
- Is the clinical impression of the treating physician that of an adequate clinical response? (Y/N) The patient is deemed to have achieved 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".
- Patient compliance with PMIM treatment [ Time Frame: 22 days ]Proportion of patients complying with prescribed 21 daily injections over no more than 22 days.
- 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 ]
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.
- To introduce PMIM in government health facilities in rural Bangladesh. [ Time Frame: October 2011 ]Training study staff to provide treatment with PMIM at selected Upazila level health complexes in rural Bangladesh.
Information By: PATH
Dates:
Date Received: January 21, 2011
Date Started: January 2011
Date Completion:
Last Updated: April 2, 2014
Last Verified: August 2012
