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

This study has been completed.
Sponsor:
Collaborators:
International Centre for Diarrhoeal Disease Research, Bangladesh
Shaheed Suhrawardy Medical College Hospital, Dhaka, Bangladesh
GVK Biosciences Private Limited, Gurgaon, India
Information provided by (Responsible Party):
PATH
ClinicalTrials.gov Identifier:
NCT01328457
First received: January 21, 2011
Last updated: April 2, 2014
Last verified: August 2012

January 21, 2011
April 2, 2014
January 2011
May 2011   (final data collection date for primary outcome measure)
Final cure rate [ Time Frame: 6 months after end of treatment (Day 202/203, -15 to +30 days) ] [ Designated as safety issue: No ]

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.

Final cure rate [ Time Frame: 6 months after end of treatment (Day 202/203, -15 to +30 days) ] [ Designated as safety issue: No ]

The following criteria will be evaluated in a binary fashion:

  1. Is the patient's temperature less than 99.4°F in clinic at EOT visit? (Y/N)
  2. Has the patient reported resolution of fever and NO fever within the last 5 days? (Y/N)
  3. Has 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".

Complete list of historical versions of study NCT01328457 on ClinicalTrials.gov Archive Site
  • Initial clinical response rate [ Time Frame: End of treatment (21/22 days after treatment begins) ] [ Designated as safety issue: No ]

    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 / NO fever within the last 5 days? (Y/N)
    3. Spleen size decreased from screening value? (Y/N)
    4. 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]
    Training study staff to provide treatment with PMIM at selected Upazila level health complexes in rural Bangladesh.
  • Initial clinical response rate [ Time Frame: End of treatment (21/22 days after treatment begins) ] [ Designated as safety issue: No ]

    The following criteria will be evaluated in a binary fashion:

    1. Is the patient's temperature less than 99.4°F in clinic at EOT visit? (Y/N)
    2. Has the patient reported resolution of fever and NO fever within the last 5 days? (Y/N)
    3. Has 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 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]
    Training study staff to provide treatment with PMIM at selected Upazila level health complexes in rural Bangladesh.
Not Provided
Not Provided
 
An Effectiveness Study of Paromomycin IM Injection (PMIM) for the Treatment of Visceral Leishmaniasis (VL) in Bangladesh
An Effectiveness Study of Paromomycin IM Injection (PMIM) for the Treatment of Visceral Leishmaniasis (VL) in Bangladesh

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).

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Visceral Leishmaniasis
Drug: 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).
Other 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
June 2012
May 2011   (final data collection date for primary outcome measure)

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
Both
5 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Bangladesh
 
NCT01328457
VLPMIM402
Yes
PATH
PATH
  • International Centre for Diarrhoeal Disease Research, Bangladesh
  • Shaheed Suhrawardy Medical College Hospital, Dhaka, Bangladesh
  • GVK Biosciences Private Limited, Gurgaon, India
Principal Investigator: Rashidul Haque, MB, PhD International Centre for Diarrheal Disease Research, Bangladesh
PATH
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP