Cutaneous LeishmaniasisPhase 2GMCSFSbvNCT00973128
Reduced Doses of Antimony Plus Ranulocyte Monocyte Colony Stimulating Factor (GM-CSF) for Cutaneous Leishmaniasis
A Phase 2 study testing GMCSF plus Antimony reduced dose and Meglumine antimoniate in people with Cutaneous Leishmaniasis, run by Hospital Universitário Professor Edgard Santos at 1 site in Brazil.
Trial summary
The present study was designed as a randomized, single blind, placebo-controlled, study to evaluate the effect of 400 µg of recombinant human GM-CSF applied intralesionally and associated with half of the total dose of antimony in a reduced time schedule (20mgSbV/Kg/d for 10 days) as compared to the full dose of… Read more about this study
- Who is it for?
- Ages 15 to 50 years
- Conditions the study is for
- Cutaneous Leishmaniasis
- What is being tested?
- GMCSF plus Antimony reduced dose and Meglumine antimoniate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2004to May 2007
- Phase
- Phase 2
- 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 15 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age between 15 and 50 years
- Either gender
- Diagnosis of cutaneous leishmaniasis
- Less than 60 days of disease
Who cannot join
- Any history of prior anti-leishmania therapy
- Negative parasitology (aspirate/smear)or negative Montenegro test
- Pregnancy
- Age below 15 and above 50 years
- Other associated acute or chronic illnesses
- History of allergy to GM-CSF and/or antimony
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- HIV, HTLV-1 infections or diabetes
- Administrative reasons:
- Lack of ability or willingness to give informed consent (patient and/or parent / legal representative)
- Anticipated non-availability for study visits/procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reduced Doses of Antimony Plus Recombinant Human GM-CSF Compared With Antimony in Standard Doses for Cutaneous Leishmaniasis: a Randomized, Single-blind, Placebo-controlled, Pilot Study
The present study was designed as a randomized, single blind, placebo-controlled, study to evaluate the effect of 400 µg of recombinant human GM-CSF applied intralesionally and associated with half of the total dose of antimony in a reduced time schedule (20mgSbV/Kg/d for 10 days) as compared to the full dose of antimony (20mgSbV/Kg/d for 20 days) to treat cutaneous leishmaniasis ulcers.
Read the detailed description
This is a randomized, single blind placebo-controlled study in which the groups were selected from the cases presenting to the health post. The inclusion criteria were: age between 15 and 50 years, of either sex, diagnosis of cutaneous leishmaniasis of less than 60 days. The diagnostic criteria were the presence of a typical single cutaneous ulcer, localized on lower limbs, and a positive delayed type hypersensitivity test (DTH or Montenegro skin test) to Leishmania antigen.
- Conditions
- Cutaneous Leishmaniasis
- Being tested
- GMCSF plus Antimony reduced dose, Meglumine antimoniate
- Medical subject headings
- Leishmaniasis, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GMCSF plus Antimony reduced doseDrug
Also called Sargramostim
400 µg, divided in two doses a week apart, antimony (20mg/daily for 10 days)
Meglumine antimoniateDrug
Also called pentavalent antimony
20mg/daily for 20 days
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Group 1: Cutaneous leishmaniasis patients randomized in Corte to receive antimony (20mg/daily for 10 days) plus GM-CSF Treatment: antimony (20mg/daily for 10 days) plus GM-CSF (400 µg, divided in two doses a week apart) Receives: Drug: GMCSF plus Antimony reduced dose |
| Group 2 | Active comparator | Group 2: antimony in standard dose plus saline administered in an identical fashion to the GM-CSF. Receives: Drug: Meglumine antimoniate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure rate or complete cicatrization of the ulcer
Measured: 3 months after treatment
Secondary outcomes (1)
Initial cure rate or complete cicatrization of the ulcer.
Measured: 2 months after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2009 (estimated)
- Study startFeb 2004
- Primary completionOct 2006
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitário Professor Edgard Santos
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado da Bahia
- Investigators
- Roque P Almeida, MD, PhD, Principal investigator, Hospital Universitário Prof Edgard Santos-UFBA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00973128
- Sponsor's protocol ID
- GMCSFAntimonyCL
- Acronym
- GMCSFSbv
- Status last verified
- Sep 2009
- First submitted
- 8 Sep 2009
- Last updated
- 9 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduced Doses of Antimony Plus Recombinant Human GM-CSF Compared With Antimony in Standard Doses for Cutaneous Leishmaniasis: a Randomized, Single-blind, Placebo-controlled, Pilot Study
- ClinicalTrials.gov ID
- NCT00973128
- Acronym / sponsor ID
- GMCSFSbv / GMCSFAntimonyCL
- Conditions
- Cutaneous Leishmaniasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hospital Universitário Professor Edgard SantosUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado da Bahia
- Study start
- Feb 2004
- Primary completion
- Oct 2006 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 9 Sep 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 present study was designed as a randomized, single blind, placebo-controlled, study to evaluate the effect of 400 µg of recombinant human GM-CSF applied intralesionally and associated with half of the total dose of antimony in a reduced time schedule (20mgSbV/Kg/d for 10 days) as compared to the full dose of antimony (20mgSbV/Kg/d for 20 days) to treat cutaneous leishmaniasis ulcers.
Detailed description
This is a randomized, single blind placebo-controlled study in which the groups were selected from the cases presenting to the health post. The inclusion criteria were: age between 15 and 50 years, of either sex, diagnosis of cutaneous leishmaniasis of less than 60 days. The diagnostic criteria were the presence of a typical single cutaneous ulcer, localized on lower limbs, and a positive delayed type hypersensitivity test (DTH or Montenegro skin test) to Leishmania antigen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: GMCSF plus Antimony reduced doseGroup 1: Cutaneous leishmaniasis patients randomized in Corte to receive antimony (20mg/daily for 10 days) plus GM-CSF Treatment: antimony (20mg/daily for 10 days) plus GM-CSF (400 µg, divided in two doses a week apart) |
| Group 2 | Active comparator | Drug: Meglumine antimoniateGroup 2: antimony in standard dose plus saline administered in an identical fashion to the GM-CSF. |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age between 15 and 50 years
- Either gender
- Diagnosis of cutaneous leishmaniasis
- Less than 60 days of disease
Key exclusion criteria (10 listed)
- Any history of prior anti-leishmania therapy
- Negative parasitology (aspirate/smear)or negative Montenegro test
- Pregnancy
- Age below 15 and above 50 years
- Other associated acute or chronic illnesses
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 |
|---|---|---|
| GMCSF plus Antimony reduced doseAlso: Sargramostim400 µg, divided in two doses a week apart, antimony (20mg/daily for 10 days) | Drug | Group 1 |
| Meglumine antimoniateAlso: pentavalent antimony20mg/daily for 20 days | Drug | Group 2 |
Primary outcome
Cure rate or complete cicatrization of the ulcer
Time frame: 3 months after treatment
1 secondary outcome
Initial cure rate or complete cicatrization of the ulcer.
Time frame: 2 months after treatment.
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 9 Sep 2009.
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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.
Roque P Almeida, MD, PhD principal investigator
Hospital Universitário Prof Edgard Santos-UFBA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GMCSF plus Antimony reduced dose and Meglumine antimoniate in people with Cutaneous Leishmaniasis, run by Hospital Universitário Professor Edgard Santos at 1 site 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 4 inclusion and 10 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 9 Sep 2009. 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 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 or complete cicatrization of the ulcer (time frame: 3 months after treatment). 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 9 Sep 2009.