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Visceral LeishmaniasisNCT01328457

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

A study testing Paromomycin sulfate in people with Visceral Leishmaniasis, run by PATH at 3 sites in Bangladesh.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 5 to 55 years
Conditions the study is for
Visceral Leishmaniasis
What is being tested?
Paromomycin sulfate
Type of treatment
Injection or infusion
How many people
120 participants
Where
3 sitesBangladesh
Study dates
Jan 2011to Jun 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 55 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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:
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

3 sites in 1 country.

Bangladesh3 sites

  • Bhaluka Upazila Health Complex

    Bhaluka, Mymensingh District

  • Icddr,B

    Dhaka

  • Trishal Upazila Health Complex

    Trishal, Mymensingh District

Other trials in Bangladesh

About this study

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).

Read the 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.

Being tested
Paromomycin sulfate
Keywords
Leishmaniasis, Visceral, kala-azar, Paromomycin, Bangladesh, Injections, Intramuscular, Treatment Outcome, Patient compliance, Medication adherence, Drug toxicity
Medical subject headings
Leishmaniasis, Visceral, Patient Compliance, Medication Adherence, Drug-Related Side Effects and Adverse Reactions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Paromomycin sulfateDrug

    Also called aminosidin sulfate, aminosidine sulfate, monomycin A sulfate, amminosidin 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).

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (4)

  1. Initial clinical response 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 / 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.

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

  2. Patient compliance with PMIM treatment

    Proportion of patients complying with prescribed 21 daily injections over no more than 22 days.

    Measured: 22 days

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

    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.

    Measured: 6 months after end of treatment

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

    Training study staff to provide treatment with PMIM at selected Upazila level health complexes in rural Bangladesh.

    Measured: October 2011

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2011 (estimated)
  2. Study startJan 2011
  3. Primary completionMay 2011
  4. Study completionJun 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01328457
Sponsor's protocol ID
VLPMIM402
Status last verified
Aug 2012
First submitted
21 Jan 2011
Last updated
4 Apr 2014
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 17582067

  • 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.

    PubMed 9145856

  • 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.

    PubMed 26496648

Questions about this trial

What is this clinical trial studying?

A study testing Paromomycin sulfate in people with Visceral Leishmaniasis, run by PATH at 3 sites in Bangladesh.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Final cure rate (time frame: 6 months after end of treatment (Day 202/203, -15 to +30 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01328457, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2014.

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