Visceral LeishmaniasisPhase 4NCT01566552
Single Dose Liposomal Amphotericin B for Visceral Leishmaniasis
A Phase 4 study testing AMBISOME in people with Visceral Leishmaniasis, run by Banaras Hindu University at 1 site in India.
Trial summary
The study is designed to determine the use of delivering point of care, rapid diagnosis with rK39 and treatment with AmBisome single dose of 10 mg/kg when administrated in the Primary Health Center (PHC) settings with regard to operational feasibility, safety and final cure rate at 6 months after end of treatment. Read more about this study
- Who is it for?
- Ages 5 to 65 years
- Conditions the study is for
- Visceral Leishmaniasis
- What is being tested?
- AMBISOME
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,300 participants
- Where
- 1 siteIndia
- Study dates
- Jun 2014to Dec 2017
- 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 5 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female patients ≥ 5 years of age
- History of fever for more than 2 weeks
- Splenomegaly
- rK 39 rapid test positive
- Biochemical and hematological test values as follows:
- Hemoglobin ≥ 5 g/dl
Show all 10Show fewer
- White blood cell count ≥1.0 x 109/L
- AST, ALT ≤ 3 times the upper limit of normal
- Serum creatinine level within normal limit
- Written informed consent from the patient/ or parent or guardian if under 18 years old.
Who cannot join
- A history of intercurrent or presence of clinical signs / symptoms of concurrent diseases / conditions (e.g. Chronic alcohol consumption or drug addiction, renal, hepatic, cardiovascular or CNS disease; diabetes mellitus, dehydration, other infectious diseases or major psychiatric diseases) only if the intercurrent conditions are not under control before starting the treatment with AmBisome.
- Any condition which according to the investigator might prevent the patient from completing the study therapy and subsequent follow up
- A history of allergy or hypersensitivity to Amphotericin B
- Previous treatment for VL
- Prior treatment failure with Amphotericin B
- Post Kala-azar Dermal Leishmaniasis (PKDL
Trial locations and contacts
1 site in 1 country.
India1 site
Kala Azar Medical Research Center
Muzaffarpur, Bihar, 842001
DEEPAK VERMA, MBBS, 916212287570, KMARCMFP@HOTMAIL.COM
About this study
Official title: Point of Care Diagnosis and Treatment With Single Dose Liposomal Amphotericin B for Visceral Leishmaniasis in India.
The study is designed to determine the use of delivering point of care, rapid diagnosis with rK39 and treatment with AmBisome single dose of 10 mg/kg when administrated in the Primary Health Center (PHC) settings with regard to operational feasibility, safety and final cure rate at 6 months after end of treatment. Point of care diagnosis and treatment (PCDT) at the PHC level would bring the best available interventions closer to the patients with visceral leishmaniasis (VL) whose villages are within several kilometers of the PHC. This would support the VL elimination program in the Indian subcontinent.
Read the detailed description
Primary Objectives:
To evaluate the operational feasibility of delivering point of care, rapid diagnosis with rK39 and treatment with AmBisome® single dose of 10 mg/kg, when administrated at the Primary Health Centers (PHC) setting with regard to feasibility and safety .
Secondary objectives:
To determine efficacy of the treatment scheme when delivered by district hospitals and PHC facilities
Methodology:
Three districts, Saran, Simastipur and Muzaffarpur in the VL endemic state of Bihar in India will be selected for the study. Initially, 300 eligible patients will be diagnosed and treated at hospital level with liposomal amphotericin B, using a single dose of 10 mg/kg. If no significant feasibility or safety issues are identified in this group of patients, 1000 additional subjects will be diagnosed and treated at the PHC level. Feasibility will be determined by the proportion of patients attending the PHCs treated with single dose AmBisome and the proportion of patients that need to be referred to the district hospitals for management of adverse events. The initial cure rate will be determined at day 30, after end of treatment (EOT). If initial cure is observed, the patient will be followed up and evaluated 6 months after the end of treatment for final clinical cure.
Study medication, dose and mode of administration Liposomal Amphotericin B (Gilead Sciences, Foster City, CA, USA) is formulated as a lyophilized powder which will be reconstituted in 10 ml of distilled water as a solution and the total dose will be then diluted in three times the volume of 5% dextrose solution.
Total infusion will be done in 2 hours.
Before infusion of AmBisome®, each patient will be given Paracetamol (Adult: 500 mg; Children below 12 years 10 mg/kg) and Chlorpheniramine (Adult: 4mg; Children below 12 years 1-2mg)
Parameters for evaluation Laboratory parameters for safety Adverse event
Endpoints (Feasibility)
- 85% of VL patients attending the PHCs are treated with the single dose AmBisome scheme.
- 3% of patients treated with single dose AmBisome are referred to district hospitals for AEs management .
- 95% of patients treated with single dose AmBisome are cure at 6 months after EOT.
Endpoints (Efficacy) Initial Cure: Defined as remission of fever, any decrease in spleen size compared with baseline, hemoglobin is increased by at least 10% compared to baseline or to at least 10g/dl, and improvement in other clinical signs and symptoms on day 30.
Final Cure: Defined on the fulfillment of following criteria at 6 months after EOT: No relapse after initial cure, absence of fever and no increase in spleen size compared with day 30 and hemoglobin is increased by at least10% compared to day 30 or to at least 10g/dl.
Statistical methods Efficacy analysis: Calculation of cure rate with 95% and 90% lower confidence limit according to the Clopper Pearson method.
Safety analysis: Calculation of overall incidence of adverse events.
- Conditions
- Visceral Leishmaniasis
- Being tested
- AMBISOME
- Keywords
- AMBISOME, VISCERAL LEISHMANIASIS, SINGLE DOSE
- Medical subject headings
- Leishmaniasis, Visceral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMBISOMEDrug
Also called LIPOSOMAL AMPHOTERECIN B
SINGLE DOSE AMBISOME FOR TREATMENT OF VISCERAL LEISHMANIASIS
| Study group | Role | What they receive |
|---|---|---|
| SINGLE DOSE AMBISOME | Other | Not described Receives: Drug: AMBISOME |
What is being measured
The primary outcome is the main question the study is designed to answer.
CLINICAL CURE
Measured: 24 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2012 (estimated)
- Study startJun 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 1,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Banaras Hindu University
- Sponsor type
- University, hospital or other
- Collaborators
- Rajendra Memorial Research Institute of Medical Sciences
- Responsible party
- Principal investigator, Shyam Sundar, Banaras Hindu University
- Investigators
- SHYAM SUNDAR, M.D., Principal investigator, Banaras Hindu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01566552
- Sponsor's protocol ID
- BHU001/2012
- Status last verified
- Mar 2012
- First submitted
- 27 Mar 2012
- Last updated
- 22 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point of Care Diagnosis and Treatment With Single Dose Liposomal Amphotericin B for Visceral Leishmaniasis in India.
- ClinicalTrials.gov ID
- NCT01566552
- Acronym / sponsor ID
- BHU001/2012
- Conditions
- Visceral Leishmaniasis
- Keywords
- AMBISOME, VISCERAL LEISHMANIASIS, SINGLE DOSE
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,300 participants (estimated)
- Lead sponsor
- Banaras Hindu UniversityUniversity, hospital or other
- Collaborators
- Rajendra Memorial Research Institute of Medical Sciences
- Study start
- Jun 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 29 Mar 2012 (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.
The study is designed to determine the use of delivering point of care, rapid diagnosis with rK39 and treatment with AmBisome single dose of 10 mg/kg when administrated in the Primary Health Center (PHC) settings with regard to operational feasibility, safety and final cure rate at 6 months after end of treatment. Point of care diagnosis and treatment (PCDT) at the PHC level would bring the best available interventions closer to the patients with visceral leishmaniasis (VL) whose villages are within several kilometers of the PHC. This would support the VL elimination program in the Indian subcontinent.
Detailed description
Primary Objectives:
To evaluate the operational feasibility of delivering point of care, rapid diagnosis with rK39 and treatment with AmBisome® single dose of 10 mg/kg, when administrated at the Primary Health Centers (PHC) setting with regard to feasibility and safety .
Secondary objectives:
To determine efficacy of the treatment scheme when delivered by district hospitals and PHC facilities
Methodology:
Three districts, Saran, Simastipur and Muzaffarpur in the VL endemic state of Bihar in India will be selected for the study. Initially, 300 eligible patients will be diagnosed and treated at hospital level with liposomal amphotericin B, using a single dose of 10 mg/kg. If no significant feasibility or safety issues are identified in this group of patients, 1000 additional subjects will be diagnosed and treated at the PHC level. Feasibility will be determined by the proportion of patients attending the PHCs treated with single dose AmBisome and the proportion of patients that need to be referred to the district hospitals for management of adverse events. The initial cure rate will be determined at day 30, after end of treatment (EOT). If initial cure is observed, the patient will be followed up and evaluated 6 months after the end of treatment for final clinical cure.
Study medication, dose and mode of administration Liposomal Amphotericin B (Gilead Sciences, Foster City, CA, USA) is formulated as a lyophilized powder which will be reconstituted in 10 ml of distilled water as a solution and the total dose will be then diluted in three times the volume of 5% dextrose solution.
Total infusion will be done in 2 hours.
Before infusion of AmBisome®, each patient will be given Paracetamol (Adult: 500 mg; Children below 12 years 10 mg/kg) and Chlorpheniramine (Adult: 4mg; Children below 12 years 1-2mg)
Parameters for evaluation Laboratory parameters for safety Adverse event
Endpoints (Feasibility)
- 85% of VL patients attending the PHCs are treated with the single dose AmBisome scheme.
- 3% of patients treated with single dose AmBisome are referred to district hospitals for AEs management .
- 95% of patients treated with single dose AmBisome are cure at 6 months after EOT.
Endpoints (Efficacy) Initial Cure: Defined as remission of fever, any decrease in spleen size compared with baseline, hemoglobin is increased by at least 10% compared to baseline or to at least 10g/dl, and improvement in other clinical signs and symptoms on day 30.
Final Cure: Defined on the fulfillment of following criteria at 6 months after EOT: No relapse after initial cure, absence of fever and no increase in spleen size compared with day 30 and hemoglobin is increased by at least10% compared to day 30 or to at least 10g/dl.
Statistical methods Efficacy analysis: Calculation of cure rate with 95% and 90% lower confidence limit according to the Clopper Pearson method.
Safety analysis: Calculation of overall incidence of adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SINGLE DOSE AMBISOME | Other | Drug: AMBISOME |
Who may qualify
- Ages
- 5 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female patients ≥ 5 years of age
- History of fever for more than 2 weeks
- Splenomegaly
- rK 39 rapid test positive
- Biochemical and hematological test values as follows:
Key exclusion criteria (6 listed)
- A history of intercurrent or presence of clinical signs / symptoms of concurrent diseases / conditions (e.g. Chronic alcohol consumption or drug addiction, renal, hepatic, cardiovascular or CNS disease; diabetes mellitus, dehydration, other infectious diseases or major psychiatric diseases) only if the intercurrent conditions are not under control before starting the treatment with AmBisome.
- Any condition which according to the investigator might prevent the patient from completing the study therapy and subsequent follow up
- A history of allergy or hypersensitivity to Amphotericin B
- Previous treatment for VL
- Prior treatment failure with Amphotericin B
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 |
|---|---|---|
| AMBISOMEAlso: LIPOSOMAL AMPHOTERECIN BSINGLE DOSE AMBISOME FOR TREATMENT OF VISCERAL LEISHMANIASIS | Drug | SINGLE DOSE AMBISOME |
Primary outcome
CLINICAL CURE
Time frame: 24 MONTHS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2014.
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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.
SHYAM SUNDAR, M.D. principal investigator
Banaras Hindu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing AMBISOME in people with Visceral Leishmaniasis, run by Banaras Hindu University at 1 site 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 10 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 22 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ANUP SINGH, M.D. (09198332093, DRANUPBHU@GMAIL.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CLINICAL CURE (time frame: 24 MONTHS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jan 2014.