Visceral LeishmaniasisPhase 4NCT00604955
Expand Access/Assess Safety and Efficacy of Paromomycin IM Injection for the Treatment of Visceral Leishmaniasis
A Phase 4 study testing Paromomycin sulfate in people with Visceral Leishmaniasis, run by PATH at 7 sites in India.
Trial summary
This modular Program will first confirm the safety and efficacy of Paromomycin IM Injection when given to an expanded population in the outpatient setting in experienced VL centers and subsequently evaluate the effectiveness of an expanded access model of providing Paromomycin IM Injection to progressively more… Read more about this study
- Who is it for?
- Ages 2 to 55 years
- Conditions the study is for
- Visceral Leishmaniasis
- What is being tested?
- Paromomycin sulfate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 7 sitesIndia
- Study dates
- Oct 2007to Jan 2010
- Phase
- Phase 4
- 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 2 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Confirmed, newly diagnosed or relapsed visceral leishmaniasis
Who cannot join
- HIV infection, tuberculosis
- Significant hematologic, renal or liver dysfunction
- Malaria
- Those unable to be treated as an outpatient.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
India7 sites
Rajendra Memorial Research Institute of Medical Sciences
Agam Kuan, Patna, Bihar, 800 007
Shrimati Hazari Maternity and Medical Care
Azad Nagar, Balua Tal, Motihari, Bihar, 845 401
Research Centre for Diabetes, Hypertension and Obesity
Bengali Tola, Samastipur, Bihar, 848 101
Kalazar Research Centre
Brahmpura, Muzaffarpur, Bihar, 842 003
Dr. A.K. Aditya Clinic
East of Bhola Talkies, Samastipur, Bihar, 848 101
Kala-zar Research Centre
Patna, Bihar, 800 001
Kala-azar Medical Research Centre
Rambagh Road, Muzaffarpur, Bihar, 842 001
About this study
Official title: A Phase 4 Study to Expand Access Program While Assessing the Safety and Efficacy of Paromomycin IM Injection in an Outpatient Setting for the Treatment of Visceral Leishmaniasis
This modular Program will first confirm the safety and efficacy of Paromomycin IM Injection when given to an expanded population in the outpatient setting in experienced VL centers and subsequently evaluate the effectiveness of an expanded access model of providing Paromomycin IM Injection to progressively more resource-constrained clinics in Bihar, India.
Read the detailed description
Safe, effective, and affordable treatments for visceral leishmaniasis (VL) that are widely available to the poorest population of rural India where the disease is endemic are urgently needed. Resistance to antimonials, which have historically been the first line of treatment for VL in Bihar and adjoining states, is a major problem. Other available treatments are limited by their high cost, toxicity, or contraindications in certain populations. Paromomycin IM Injection was approved for the treatment of VL in August 2006 by the Drug Controller General of India (DCGI).
The study is designed to establish a Phase 4 Access Program in a modular, stepwise fashion (Modules 1 to 3). The study will first confirm the safety and efficacy of Paromomycin IM Injection in an expanded VL population treated as an outpatient in experienced centers (Module 1); and then progressively extend the network of treatment facilities, the number and reach of the trained staff, and the implementation of the requisite logistics systems to rural Bihar (Modules 2 and 3). An expanded network of healthcare workers will be trained and supervised to make a preliminary diagnosis of VL; to make appropriate referrals to confirm the diagnosis of VL; to treat with Paromomycin IM Injection; and to assess patient safety and clinical response on an outpatient basis.
- Conditions
- Visceral Leishmaniasis
- Being tested
- Paromomycin sulfate
- Keywords
- visceral leishmaniasis, kala-azar, Bihar, India
- Medical subject headings
- Leishmaniasis, Visceral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paromomycin sulfateDrug
Also called Paromomycin IM Injection
Paromomycin will be administered intramuscularly at 11 mg/kg, once a day, for 21 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Paromomycin IM Injection (approved product in India) Receives: Drug: Paromomycin sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
M1: Safety as measured by adverse events, serious adverse events, vital signs, and laboratory parameters.
Measured: M1: Approximately 6 months
M2&3: Program effectiveness as measured by specific criteria for healthcare workers, patients, and operational systems.
Measured: approximately 2.5 years
Secondary outcomes (2)
M1: Clinical cure as measured by temperature/hx of fever, spleen size decrease by at least 33% from baseline, and clinical assessment of treating physician.
Measured: M1: Approximately 6 months
M2 and M3: Clinical cure as measured by temperature/hx of fever, spleen size decrease, and clinical assessment of treating physician.
Measured: approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2008 (estimated)
- Study startOct 2007
- Primary completionDec 2008
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Visceral LeishmaniasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- PATH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- P K Sinha, MD, Principal investigator, Rajendra Memorial Research Institute of Medical SciencesT K Jha, MD, Principal investigator, Kalazar Research CentreC P Thakur, MD, Principal investigator, Kala-azar Research CentreShyam Sundar, MD, Principal investigator, Kala-azar Medical Research CentreDevendra Nath, MD, Principal investigator, Shrimati Hazari Maternity and Medical CareSupriyo Mukherjee, MD, Principal investigator, Research Centre for Diabetes, Hypertension and ObesityAmrendra K Aditya, MD, Principal investigator, Dr. A.K. Aditya Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00604955
- Sponsor's protocol ID
- VLPM03
- Status last verified
- Oct 2014
- First submitted
- 17 Jan 2008
- Last updated
- 3 Oct 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4 Study to Expand Access Program While Assessing the Safety and Efficacy of Paromomycin IM Injection in an Outpatient Setting for the Treatment of Visceral Leishmaniasis
- ClinicalTrials.gov ID
- NCT00604955
- Acronym / sponsor ID
- VLPM03
- Conditions
- Visceral Leishmaniasis
- Keywords
- visceral leishmaniasis, kala-azar, Bihar, India
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- PATHUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 30 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This modular Program will first confirm the safety and efficacy of Paromomycin IM Injection when given to an expanded population in the outpatient setting in experienced VL centers and subsequently evaluate the effectiveness of an expanded access model of providing Paromomycin IM Injection to progressively more resource-constrained clinics in Bihar, India.
Detailed description
Safe, effective, and affordable treatments for visceral leishmaniasis (VL) that are widely available to the poorest population of rural India where the disease is endemic are urgently needed. Resistance to antimonials, which have historically been the first line of treatment for VL in Bihar and adjoining states, is a major problem. Other available treatments are limited by their high cost, toxicity, or contraindications in certain populations. Paromomycin IM Injection was approved for the treatment of VL in August 2006 by the Drug Controller General of India (DCGI).
The study is designed to establish a Phase 4 Access Program in a modular, stepwise fashion (Modules 1 to 3). The study will first confirm the safety and efficacy of Paromomycin IM Injection in an expanded VL population treated as an outpatient in experienced centers (Module 1); and then progressively extend the network of treatment facilities, the number and reach of the trained staff, and the implementation of the requisite logistics systems to rural Bihar (Modules 2 and 3). An expanded network of healthcare workers will be trained and supervised to make a preliminary diagnosis of VL; to make appropriate referrals to confirm the diagnosis of VL; to treat with Paromomycin IM Injection; and to assess patient safety and clinical response on an outpatient basis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Paromomycin sulfateParomomycin IM Injection (approved product in India) |
Who may qualify
- Ages
- 2 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Confirmed, newly diagnosed or relapsed visceral leishmaniasis
Key exclusion criteria (4 listed)
- HIV infection, tuberculosis
- Significant hematologic, renal or liver dysfunction
- Malaria
- Those unable to be treated as an outpatient.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paromomycin sulfateAlso: Paromomycin IM InjectionParomomycin will be administered intramuscularly at 11 mg/kg, once a day, for 21 consecutive days | Drug | A |
Primary outcome
M1: Safety as measured by adverse events, serious adverse events, vital signs, and laboratory parameters.
Time frame: M1: Approximately 6 months
M2&3: Program effectiveness as measured by specific criteria for healthcare workers, patients, and operational systems.
Time frame: approximately 2.5 years
2 secondary outcomes
M1: Clinical cure as measured by temperature/hx of fever, spleen size decrease by at least 33% from baseline, and clinical assessment of treating physician.
Time frame: M1: Approximately 6 months
M2 and M3: Clinical cure as measured by temperature/hx of fever, spleen size decrease, and clinical assessment of treating physician.
Time frame: approximately 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2014.
- Background: PubMed 17582067Sundar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
P K Sinha, MD principal investigator
Rajendra Memorial Research Institute of Medical Sciences
T K Jha, MD principal investigator
Kalazar Research Centre
C P Thakur, MD principal investigator
Kala-azar Research Centre
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Paromomycin sulfate in people with Visceral Leishmaniasis, run by PATH at 7 sites in India.
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 1 inclusion and 4 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 3 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in India. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
M1: Safety as measured by adverse events, serious adverse events, vital signs, and laboratory parameters. (time frame: M1: Approximately 6 months). The study lists 2 primary outcomes in all. 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 NCT00604955, which also lists 1 linked publication.
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 3 Oct 2014.