Cutaneous Leishmaniasis Clinical Trial
— LowdosesbOfficial title:
Phase IV Randomized Controlled Clinical Trial to Evaluate the Safety and Efficacy of Low-Dose Pentavalent Antimony Compared to the Standard Dose in Patients With Cutaneous Leishmaniasis Caused by Leishmania (Viannia)Braziliensis
Verified date | January 2009 |
Source | University of Brasilia |
Contact | n/a |
Is FDA regulated | No |
Health authority | Brazil: National Health Surveillance Agency |
Study type | Interventional |
The purpose of this study is to determine whether low-dose pentavalent antimony is equally effective when compared to the standard-dose regimen in patients with cutaneous leishmaniasis. The study will be done in a field clinic in the state of Bahia, Brazil.
Status | Completed |
Enrollment | 280 |
Est. completion date | December 2008 |
Est. primary completion date | March 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 7 Years to 50 Years |
Eligibility |
Inclusion Criteria: - Presence of 1 to 9 cutaneous lesions clinically compatible with leishmaniasis - Disease duration of 2 to 20 weeks - Positive leishmanin skin test - Parasitological diagnosis confirmed through culture or genus-specific polymerase chain reaction (PCR) for Leishmania spp Exclusion Criteria: - History of past episode of leishmaniasis - Mucosal disease - Disseminated disease - Use of drugs with anti-leishmanial activity - Contraindications for using pentavalent antimony: - pregnancy - renal failure - heart failure - hepatic failure - Other diseases: - active tuberculosis - hanseniasis |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Núcleo de Medicina Tropical, University of Brasilia | Brasilia | Distrito Federal |
Lead Sponsor | Collaborator |
---|---|
University of Brasilia | Ministry of Health, Brazil |
Brazil,
Oliveira-Neto MP, Schubach A, Mattos M, Goncalves-Costa SC, Pirmez C. A low-dose antimony treatment in 159 patients with American cutaneous leishmaniasis: extensive follow-up studies (up to 10 years). Am J Trop Med Hyg. 1997 Dec;57(6):651-5. — View Citation
Oliveira-Neto MP, Schubach A, Mattos M, Gonçalves-Costa SC, Pirmez C. Treatment of American cutaneous leishmaniasis: a comparison between low dosage (5 mg/kg/day) and high dosage (20 mg/kg/day) antimony regimens. Pathol Biol (Paris). 1997 Jun;45(6):496-9. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of clinically cured patients at the third month after treatment | Three months after treatment | No | |
Primary | Proportion of patients with epithelialized lesions | Three months after treatment | No | |
Secondary | Proportion of patients with adherence to the protocol prescribed drug | 30 days | No | |
Secondary | Proportion of patients with adverse events | 30 days after treatment | Yes | |
Secondary | Proportion of patients with late failure after the first three months of follow-up | 12 months | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01988909 -
WR 279,396 for the Treatment of Cutaneous Leishmaniasis
|
Phase 2 | |
Enrolling by invitation |
NCT00840359 -
Study of the Efficacy of Daylight Activated Photodynamic Therapy in the Treatment of Cutaneous Leishmaniasis
|
Phase 2 | |
Enrolling by invitation |
NCT00737386 -
Frequency of Parasite Infection in Hyraxes and Sandflies During Outbreak of Leishmania Tropica Epidemic in The West Bank
|
N/A | |
Completed |
NCT00233545 -
Miltefosine to Treat Cutaneous Leishmaniasis in Bolivia
|
Phase 2 | |
Completed |
NCT01462500 -
Pharmacokinetics of Miltefosine in Children and Adults
|
Phase 4 | |
Completed |
NCT01011309 -
A Study of the Efficacy and Safety of the LEISH-F2 + MPL-SE Vaccine for Treatment of Cutaneous Leishmaniasis
|
Phase 2 | |
Completed |
NCT01301924 -
Comparison of Standard and Alternative Antimonial Dosage in Patients With American Cutaneous Leishmaniasis
|
Phase 2/Phase 3 | |
Not yet recruiting |
NCT02281669 -
Prospective Observational Study of Intralesional Treatment With Pentostam in Cutaneous Leishmaniasis Israeli Patients
|
N/A | |
Completed |
NCT01464242 -
Add-on Study of Pentoxifylline in Cutaneous Leishmaniasis
|
Phase 2/Phase 3 | |
Completed |
NCT01790659 -
Phase 3 Study of Walter Reed (WR) 279,396 and Paromomycin Alone for the Treatment of Cutaneous Leishmaniasis in Panama
|
Phase 3 | |
Completed |
NCT01050907 -
Miltefosine to Treat Mucocutaneous Leishmaniasis
|
Phase 2 | |
Completed |
NCT04340128 -
Efficacy of Intra-lesional Injections of Glucantime Once a Week or Twice a Week in the Treatment of Anthroponotic Cutaneous Leishmaniasis (ACL)
|
Phase 3 | |
Completed |
NCT00351520 -
Efficacy Trial on Oral Miltefosine in Comparison With Glucantime in the Treatment of ACL Caused by L. Tropica
|
Phase 3 | |
Terminated |
NCT00317629 -
Controlled Nitric Oxide Releasing Patch Versus Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis
|
Phase 3 | |
Completed |
NCT01381055 -
Antimony Plus Pentoxifylline in Cutaneous Leishmaniasis
|
Phase 2/Phase 3 | |
Completed |
NCT01050777 -
Efficacy of Topical Liposomal Form of Drugs in Cutaneous Leishmaniasis
|
Phase 0 | |
Completed |
NCT01380314 -
Oral Miltefosine Plus Topical Imiquimod to Treat Cutaneous Leishmaniasis
|
Phase 2 | |
Terminated |
NCT01380301 -
Treatment of Cutaneous Leishmaniasis With a Combination of Miltefosine and Antimony
|
Phase 2 | |
Completed |
NCT00703924 -
Topical Treatment of Cutaneous Leishmaniasis With WR 279,396: A Phase 2 Study in the Old World
|
Phase 2 | |
Completed |
NCT00344084 -
Surveillance for Leishmaniasis Skin Lesions in Mali
|