Visceral LeishmaniasisPhase 3NCT00216346
Safety and Efficacy Study of Paromomycin to Treat Visceral Leishmaniasis
A Phase 3 study testing Paromomycin sulfate and Amphotericin B in people with Visceral Leishmaniasis, run by PATH at 4 sites in India.
Trial summary
Symptomatic Visceral Leishmaniasis(VL)is fatal; Due to the increasing resistance to standard therapy with antimonials, there is a need for new safe, efficacious, low-cost therapies for the treatment of VL. Paromomycin is an off-patent aminoglycoside antibiotic with anti-leishmaniasis activity. 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 and Amphotericin B
- How many people
- 667 participants
- Where
- 4 sitesIndia
- Study dates
- Jun 2003to Nov 2004
- Phase
- Phase 3
- 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
- Age between 5-55 years (inclusive) of either gender.
- Newly diagnosed VL or VL treatment failure confirmed by spleen or bone marrow aspirate.
- Clinical signs and symptoms compatible with VL: fever of over two weeks duration and splenomegaly.
- Biochemical and haematological test values as follows:
- Haemoglobin > 5.0g/100mL
- White blood cell count > 1 x109/L
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- Platelet count > 50 x 109/L
- AST, ALT and alkaline phosphatase < 3 times upper normal limit
- Prothrombin time < 5 seconds above control
- Serum creatinine levels within normal limits
- Serum potassium levels within normal limits
- HIV negative
Who cannot join
- A history of intercurrent or concurrent diseases (e.g. chronic alcohol consumption or drug addiction; renal, hepatic, cardiovascular or central nervous system disease; diabetes; tuberculosis or other infectious or major psychiatric diseases) that may introduce variables affecting the outcome of the study.
- Any condition which the investigator thinks may prevent the patient from completing the study therapy and subsequent follow-up.
- An abnormal baseline audiogram (presentation with 75 dB or higher at 8KHz or below) and/or a history of significant vestibular or auditory dysfunction.
- Proteinuria (> 2+).
- A history of allergy or hypersensitivity to aminoglycosides.
- A history of major surgery within the last two weeks.
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- Pregnancy or lactation. [Note: women of childbearing age must use an adequate form of contraception (documented) or agree to a period of sexual abstinence during the treatment phase of the study.]
- Previous treatment for VL within two weeks of enrolment into the study.
- Prior treatment failures with paromomycin or amphotericin B.
Trial locations and contacts
4 sites in 1 country.
India4 sites
Rajendra Memorial Research Institute of Medical Sciences (ICMR)
Agam Kuan, Patna, Bihar, 800 007
Kalazar Research Centre
Brahmpura, Muzaffarpur, Bihar, 842003
Kalazar Research Centre
Patna, Bihar, 800001
Kala-azar Medical Research Centre
Rambagh Road Muzaffarpur, Bihar, 842001
About this study
Official title: A Phase 3 Multicenter, Randomized, Controlled, Clinical Trial to Assess the Safety and Efficacy of Injectable Paromomycin in Patients With Visceral Leishmaniasis
Symptomatic Visceral Leishmaniasis(VL)is fatal; Due to the increasing resistance to standard therapy with antimonials, there is a need for new safe, efficacious, low-cost therapies for the treatment of VL. Paromomycin is an off-patent aminoglycoside antibiotic with anti-leishmaniasis activity. This study will test the safety and efficacy of paromomycin in the treatment of patients with VL in India.
- Conditions
- Visceral Leishmaniasis
- Being tested
- Paromomycin sulfate, Amphotericin B
- 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
Amphotericin BDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
(1) To compare the safety of injectable paromomycin to amphotericin B when administered in the proposed dosage regimens.
(2) To compare the efficacy of injectable paromomycin to amphotericin B with regards to final cure rates.
Secondary outcomes (3)
- Characterization of the pharmacokinetics of injectable paromomycin in adults and children with VL
- Comparison of initial cure rates for the two regimens
- Comparison of clinical improvement rates for the two regimens
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJun 2003
- Study completionNov 2004
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 667 participants
Sponsor and investigators
- Lead sponsor
- PATH
- Sponsor type
- University, hospital or other
- Collaborators
- World Health Organization
- Investigators
- Prof S. Sundar, Principal investigator, Kala-azar Research CentreProf T.K. Jha, Principal investigator, Kalazar Research CentreProf C.P. Thakur, Principal investigator, Kalazar Research CentreDr. S.K. Bhattacharya, Principal investigator, Rajendra Memorial Research Institute of Medical Sciences (ICMR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00216346
- Sponsor's protocol ID
- VLPM01
- Status last verified
- Oct 2014
- First submitted
- 13 Sep 2005
- Last updated
- 3 Oct 2014
- Results posted
- No
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 3 Multicenter, Randomized, Controlled, Clinical Trial to Assess the Safety and Efficacy of Injectable Paromomycin in Patients With Visceral Leishmaniasis
- ClinicalTrials.gov ID
- NCT00216346
- Acronym / sponsor ID
- VLPM01
- Conditions
- Visceral Leishmaniasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 667 participants
- Lead sponsor
- PATHUniversity, hospital or other
- Collaborators
- World Health Organization
- Study start
- Jun 2003
- Study completion
- Nov 2004
- First posted
- 22 Sep 2005 (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.
Symptomatic Visceral Leishmaniasis(VL)is fatal; Due to the increasing resistance to standard therapy with antimonials, there is a need for new safe, efficacious, low-cost therapies for the treatment of VL. Paromomycin is an off-patent aminoglycoside antibiotic with anti-leishmaniasis activity. This study will test the safety and efficacy of paromomycin in the treatment of patients with VL in India.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 5 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- Age between 5-55 years (inclusive) of either gender.
- Newly diagnosed VL or VL treatment failure confirmed by spleen or bone marrow aspirate.
- Clinical signs and symptoms compatible with VL: fever of over two weeks duration and splenomegaly.
- Biochemical and haematological test values as follows:
- HIV negative
Key exclusion criteria (9 listed)
- A history of intercurrent or concurrent diseases (e.g. chronic alcohol consumption or drug addiction; renal, hepatic, cardiovascular or central nervous system disease; diabetes; tuberculosis or other infectious or major psychiatric diseases) that may introduce variables affecting the outcome of the study.
- Any condition which the investigator thinks may prevent the patient from completing the study therapy and subsequent follow-up.
- An abnormal baseline audiogram (presentation with 75 dB or higher at 8KHz or below) and/or a history of significant vestibular or auditory dysfunction.
- Proteinuria (> 2+).
- A history of allergy or hypersensitivity to aminoglycosides.
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 sulfate | Drug | – |
| Amphotericin B | Drug | – |
Primary outcome
(1) To compare the safety of injectable paromomycin to amphotericin B when administered in the proposed dosage regimens.
(2) To compare the efficacy of injectable paromomycin to amphotericin B with regards to final cure rates.
3 secondary outcomes
- Characterization of the pharmacokinetics of injectable paromomycin in adults and children with VL
- Comparison of initial cure rates for the two regimens
- Comparison of clinical improvement rates for the two regimens
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.
- Derived from this study: 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.
Prof S. Sundar principal investigator
Kala-azar Research Centre
Prof T.K. Jha principal investigator
Kalazar Research Centre
Prof C.P. Thakur principal investigator
Kalazar Research Centre
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Paromomycin sulfate and Amphotericin B in people with Visceral Leishmaniasis, run by PATH at 4 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 12 inclusion and 9 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 4 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
(1) To compare the safety of injectable paromomycin to amphotericin B when administered in the proposed dosage regimens.. 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 NCT00216346, 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.