Visceral LeishmaniasisPhase 4LVTONCT01032187
Amphotericin B to Treat Visceral Leishmaniasis in Brazilian Children
A Phase 4 study testing Meglumine antimoniate and Amphotericin B-deoxycholate in people with Visceral Leishmaniasis, run by University of Brasilia at 2 sites in Brazil.
Trial summary
The purpose of this study is to determine if amphotericin B is effective against visceral leishmaniasis in Brazilian children. Amphotericin B will be compared to meglumine antimoniate which is the current approved drug used for this disease in Brazil. Read more about this study
- Who is it for?
- Ages 6 months to 12 years
- Conditions the study is for
- Visceral Leishmaniasis
- What is being tested?
- Meglumine antimoniate and Amphotericin B-deoxycholate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 2 sitesBrazil
- Study dates
- Oct 2007to Jul 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 6 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinical symptoms of visceral leishmaniasis: fever plus hepatomegaly or splenomegaly
- Diagnosis of visceral leishmaniasis confirmed through parasite visualization in bone marrow smears or positive serology (indirect immunofluorescent antibody test or rK39 rapid test)or positive kDNA PCR test
Who cannot join
- Any of the following laboratory findings
- Total serum bilirubin higher than 2,5 mg/dL
- Serum SGOT higher than 5 times the upper normal level
- Serum SGPT higher than 5 times the upper normal level
- Prothrombin time concentration lower than 70%
- Abnormal serum creatinine
Show all 17Show fewer
- Any of the following signs or symptoms
- Generalized edema
- Severe malnutrition
- Systemic inflammatory response syndrome
- Any of the following conditions
- HIV infection/disease
- Diabetes
- Corticoid or immunosuppressive drugs use
- Symptomatic heart diseases
- Chronic hepatic or renal diseases
- Lupus erythematosus
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Hospital de Doenças Tropicais
Araguaína, Tocantins
Hospital Dona Regina
Palmas, Tocantins
About this study
Official title: Efficacy and Safety of Amphotericin B Deoxycholate Compared to Meglumine Antimoniate for Treatment of Visceral Leishmaniasis in Brazilian Children
The purpose of this study is to determine if amphotericin B is effective against visceral leishmaniasis in Brazilian children. Amphotericin B will be compared to meglumine antimoniate which is the current approved drug used for this disease in Brazil.
Read the detailed description
Despite their high toxicity, antimonials and amphotericin B deoxycholate are commonly used for treating visceral leishmaniasis (VL). Few studies showing conflictive data about their efficacy and adverse events in pediatric population are available. This study aimed to evaluate efficacy and safety of amphotericin B deoxycholate vs. that of N-methylglucamine antimoniate in treating pediatric VL in Brazil. This was a randomized, open-label, 2-arm and controlled pilot clinical trial. Treatment naïve children and adolescents with VL without signs of severe illness were treated with N-methylglucamine antimoniate or amphotericin B deoxycholate. All patients were diagnosed with positive direct examination and/or positive PCR for Leishmania spp. performed in bone marrow samples. The primary efficacy end-point was VL cure determined after 180 days of completion of treatment. The analysis was performed using intention-to-treat (ITT) and per protocol (PP) analyses.
- Conditions
- Visceral Leishmaniasis
- Being tested
- Meglumine antimoniate, Amphotericin B-deoxycholate
- Keywords
- Visceral leishmaniasis, Amphotericin B deoxycholate, Meglumine antimoniate, Children, Brazil
- Medical subject headings
- Leishmaniasis, Visceral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meglumine antimoniateDrug
Also called Glucantime
20mg/kg/day IV for 20 days
Amphotericin B-deoxycholateDrug
Also called Fungizone
Amphotericin B-deoxycholate 1 mg/kg/day IV for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Meglumine antimoniate | Active comparator | 20mg/kg/day IV for 20 days Receives: Drug: Meglumine antimoniate |
| Anfo B | Experimental | Amphotericin B-deoxycholate, 1mg/kg/day IV for 14 days Receives: Drug: Amphotericin B-deoxycholate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure rate
Measured: 3 months
Secondary outcomes (2)
Improvement rate
Measured: 30 days
Adverse events rate
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2009 (estimated)
- Study startOct 2007
- Primary completionJan 2010
- Study completionJul 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Brasilia
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Brazil
- Responsible party
- Principal investigator, Gustavo Adolfo Sierra Romero, University of Brasilia
- Investigators
- Myrlena RM Borges, MsC, Principal investigator, Federal University of TocantinsGustavo AS Romero, PhD, Study chair, University of Brasilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01032187
- Sponsor's protocol ID
- LVTO-I
- Acronym
- LVTO
- Status last verified
- Aug 2017
- First submitted
- 14 Dec 2009
- Last updated
- 5 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Borges MM, Pranchevicius MC, Noronha EF, Romero GA, Carranza-Tamayo CO. Efficacy and safety of amphotericin B deoxycholate versus N-methylglucamine antimoniate in pediatric visceral leishmaniasis: an open-label, randomized, and controlled pilot trial in Brazil. Rev Soc Bras Med Trop. 2017 Jan-Feb;50(1):67-74. doi: 10.1590/0037-8682-0455-2016.
PubMed 28327804
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Amphotericin B Deoxycholate Compared to Meglumine Antimoniate for Treatment of Visceral Leishmaniasis in Brazilian Children
- ClinicalTrials.gov ID
- NCT01032187
- Acronym / sponsor ID
- LVTO / LVTO-I
- Conditions
- Visceral Leishmaniasis
- Keywords
- Visceral leishmaniasis, Amphotericin B deoxycholate, Meglumine antimoniate, Children, Brazil
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University of BrasiliaUniversity, hospital or other
- Collaborators
- Ministry of Health, Brazil
- Study start
- Oct 2007
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 15 Dec 2009 (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 purpose of this study is to determine if amphotericin B is effective against visceral leishmaniasis in Brazilian children. Amphotericin B will be compared to meglumine antimoniate which is the current approved drug used for this disease in Brazil.
Detailed description
Despite their high toxicity, antimonials and amphotericin B deoxycholate are commonly used for treating visceral leishmaniasis (VL). Few studies showing conflictive data about their efficacy and adverse events in pediatric population are available. This study aimed to evaluate efficacy and safety of amphotericin B deoxycholate vs. that of N-methylglucamine antimoniate in treating pediatric VL in Brazil. This was a randomized, open-label, 2-arm and controlled pilot clinical trial. Treatment naïve children and adolescents with VL without signs of severe illness were treated with N-methylglucamine antimoniate or amphotericin B deoxycholate. All patients were diagnosed with positive direct examination and/or positive PCR for Leishmania spp. performed in bone marrow samples. The primary efficacy end-point was VL cure determined after 180 days of completion of treatment. The analysis was performed using intention-to-treat (ITT) and per protocol (PP) analyses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meglumine antimoniate | Active comparator | Drug: Meglumine antimoniate20mg/kg/day IV for 20 days |
| Anfo B | Experimental | Drug: Amphotericin B-deoxycholateAmphotericin B-deoxycholate, 1mg/kg/day IV for 14 days |
Who may qualify
- Ages
- 6 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Clinical symptoms of visceral leishmaniasis: fever plus hepatomegaly or splenomegaly
- Diagnosis of visceral leishmaniasis confirmed through parasite visualization in bone marrow smears or positive serology (indirect immunofluorescent antibody test or rK39 rapid test)or positive kDNA PCR test
Key exclusion criteria (17 listed)
- Any of the following laboratory findings
- Any of the following signs or symptoms
- Any of the following conditions
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 |
|---|---|---|
| Meglumine antimoniateAlso: Glucantime20mg/kg/day IV for 20 days | Drug | Meglumine antimoniate |
| Amphotericin B-deoxycholateAlso: FungizoneAmphotericin B-deoxycholate 1 mg/kg/day IV for 14 days | Drug | Anfo B |
Primary outcome
Cure rate
Time frame: 3 months
2 secondary outcomes
Improvement rate
Time frame: 30 days
Adverse events rate
Time frame: 30 days
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 5 Sep 2017.
- Results publication: PubMed 28327804Borges MM, Pranchevicius MC, Noronha EF, Romero GA, Carranza-Tamayo CO. Efficacy and safety of amphotericin B deoxycholate versus N-methylglucamine antimoniate in pediatric visceral leishmaniasis: an open-label, randomized, and controlled pilot trial in Brazil. Rev Soc Bras Med Trop. 2017 Jan-Feb;50(1):67-74. doi: 10.1590/0037-8682-0455-2016.
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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.
Myrlena RM Borges, MsC principal investigator
Federal University of Tocantins
Gustavo AS Romero, PhD study chair
University of Brasilia
2 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 Meglumine antimoniate and Amphotericin B-deoxycholate in people with Visceral Leishmaniasis, run by University of Brasilia at 2 sites in Brazil.
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 2 inclusion and 17 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 5 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. 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?
Cure rate (time frame: 3 months). 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 NCT01032187, 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 5 Sep 2017.