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Treatment of Cutaneous Leishmaniasis in Brazil.Phase 2NCT00600548

Trial of Miltefosine in Cutaneous Leishmaniasis (Brazil)

A Phase 2 study testing Miltefosine. and Meglumine antimoniate. in people with Treatment of Cutaneous Leishmaniasis in Brazil., run by Hospital Universitário Professor Edgard Santos at 2 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The hypothesis of this trial is that the therapeutic activity and safety of oral miltefosine in Brazilian patients with cutaneous leishmaniasis is similar or superior to the intravenous standard treatment (meglumine antimoniate - Glucantime®). Read more about this study

Who is it for?
Ages 2 to 65 years
What is being tested?
Miltefosine. and Meglumine antimoniate.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
2 sitesBrazil
Study dates
Jul 2007to Jul 2009
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 2 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Newly diagnosed (untreated) cutaneous leishmaniasis with localized lesions and visualization of amastigotes in tissue samples or a positive culture or diagnosed by polymerase chain reaction (PCR) methods or by intradermal skin testing (Montenegro test).
  • Number of lesions: 1 to 5 ulcerative lesions.
  • Lesion´s diameter: 1 to 5 cm.
  • Disease duration: up to three months.

Who cannot join

  • Safety concerns:
  • Thrombocyte count <30 x 109/l
  • Leukocyte count <1 x 109/l
  • Hemoglobin <5 g/100 ml
  • ASAT, ALAT, AP >3 times upper limit of normal range
  • Bilirubin >2 times upper limit of normal range
Show all 19Show fewer
  • Serum creatinine or BUN >1.5 times upper limit of normal range
  • Evidence of serious underlying disease (cardiac, renal, hepatic or pulmonary)
  • Immunodeficiency or antibody to HIV
  • Any non-compensated or uncontrolled condition, such as active tuberculosis, malignant disease, severe malaria, HIV, or other major infectious diseases
  • Lactation, pregnancy (to be determined by adequate test) or inadequate contraception in females of childbearing potential for treatment period plus 2 months
  • Lack of suitability for the trial:
  • Negative parasitology (aspirate/smear)or negative Montenegro test
  • Any history of prior anti-leishmania therapy
  • Any condition which compromises ability to comply with the study procedures
  • Concomitant serious infection other than cutaneous
  • 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

2 sites in 1 country.

Brazil2 sites

  • Fundação de Medicina Tropical do Amazonas

    Manaus, Amazonas

  • Posto de Saúde de Corte de Pedra

    Tancredo Neto, Estado de Bahia

Other trials in Brazil

About this study

Official title: Clinical Trial to Assess Efficacy and Safety of Orally Administered Miltefosine in Brazilian Patients With Cutaneous Leishmaniasis Compared to the Standard Care as Active Control

The hypothesis of this trial is that the therapeutic activity and safety of oral miltefosine in Brazilian patients with cutaneous leishmaniasis is similar or superior to the intravenous standard treatment (meglumine antimoniate - Glucantime®).

Being tested
Miltefosine., Meglumine antimoniate.
Keywords
Cutaneous leishmaniasis, Miltefosine, Meglumine antimoniate, L. braziliensis, L. guyanensis
Medical subject headings
Leishmaniasis, Cutaneous

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Miltefosine.Drug

    Also called Impavido.

    Miltefosine: Capsules containing 10 mg or 50 mg miltefosine; administered orally for 28 days at dosage of 2.5 mg/kg body weight per day.

  • Meglumine antimoniate.Drug

    Also called Glucantime.

    Meglumine antimoniate administered by intravenous route for 20 days at the dosage of 20mg/kg/day.

  • Miltefosine.Drug

    Also called Impavido.

    Miltefosine: Capsules containing 10 mg or 50 mg miltefosine; administered orally for 28 days at dosage of 2.5 mg/kg body weight per day.

  • Meglumine antimoniate.Drug

    Also called Glucantime.

    Meglumine antimoniate administered by intravenous route for 20 days at the dosage of 20mg/kg/day.

Study groups in NCT00600548
Study groupRoleWhat they receive
1.1ExperimentalCutaneous leishmaniasis patients in Manaus-Amazonas randomized to receive Miltefosine.
Receives: Drug: Miltefosine.
1.2Active comparatorCutaneous leishmaniasis patients in Manaus-Amazonas randomized to receive Meglumine antimoniate (standard treatment).
Receives: Drug: Meglumine antimoniate.
2.1ExperimentalCutaneous leishmaniasis patients in Corte de Pedra-Bahia randomized to receive Miltefosine.
Receives: Drug: Miltefosine.
2.2Active comparatorCutaneous leishmaniasis patients in Corte de Pedra-Bahia randomized to receive Meglumine antimoniate (standard treatment).
Receives: Drug: Meglumine antimoniate.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cure rate or complete cicatrization of the ulcer.

    Bidirectional measurements of ulcers will be taken of the patients' lesions at the initial visit, and at each follow-up visit with standardized caliper. The area involved will be calculated as the product of the two measurements.

    All lesions will be categorized as either active or healed (cured) at follow-up visits. Only lesions with complete re-epithelialization, without raised borders, infiltrations or crusts will be considered healed. Evaluation of the lesions will be performed by 2 clinicians who will be unaware of the group assignment of all patients.

    Measured: 6 months after treatment.

Secondary outcomes (1)

  1. Inicial cure rate or complete cicatrization of the ulcer.

    Bidirectional measurements of ulcers will be taken of the patients' lesions at the initial visit, and at each follow-up visit with standardized caliper. The area involved will be calculated as the product of the two measurements.

    All lesions will be categorized as either active or healed (cured) at follow-up visits. Only lesions with complete re-epithelialization, without raised borders, infiltrations or crusts will be considered healed. Evaluation of the lesions will be performed by 2 clinicians who will be unaware of the group assignment of all patients.

    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.

  1. First posted25 Jan 2008 (estimated)
  2. Study startJul 2007
  3. Primary completionMar 2009
  4. Study completionJul 2009

Resources

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
None (open label)
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00600548
Sponsor's protocol ID
D-18506
Other IDs
410559/2006-7
Status last verified
Mar 2010
First submitted
2 Jan 2008
Last updated
15 Apr 2010
Results posted
No
Data monitoring committee
Yes

Publications

  • Machado PR, Ampuero J, Guimaraes LH, Villasboas L, Rocha AT, Schriefer A, Sousa RS, Talhari A, Penna G, Carvalho EM. Miltefosine in the treatment of cutaneous leishmaniasis caused by Leishmania braziliensis in Brazil: a randomized and controlled trial. PLoS Negl Trop Dis. 2010 Dec 21;4(12):e912. doi: 10.1371/journal.pntd.0000912.

    PubMed 21200420

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Miltefosine. and Meglumine antimoniate. in people with Treatment of Cutaneous Leishmaniasis in Brazil., run by Hospital Universitário Professor Edgard Santos 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 4 inclusion and 19 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 15 Apr 2010. 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 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: 6 months after treatment.). 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 NCT00600548, 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 15 Apr 2010.

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