Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01380301
Other study ID # 2007-Bol-01
Secondary ID
Status Terminated
Phase Phase 2
First received January 28, 2009
Last updated June 22, 2011
Start date March 2007
Est. completion date January 2009

Study information

Verified date June 2011
Source Foundation Fader
Contact n/a
Is FDA regulated No
Health authority Bolivia: Ethics CommitteeBolivia: Ministry of Health
Study type Interventional

Clinical Trial Summary

Cutaneous leishmaniasis is endemic in the New World and, until recently, the standard treatment was pentavalent antimony. The cure rate for L panamensis in Colombia is 91%-93% and the cure rate in Bolivia is also 90%. Nevertheless, pentavalent antimonials have the disadvantages of multiple injections and mild-moderate clinical toxicity all of which are particularly unpleasant for a moderate clinical problem such as cutaneous leishmaniasis.

The oral agent Miltefosine has now been shown to be as effective as antimony in Colombia and Bolivia (91 and 92% respectively). Side effects seen in patients with cutaneous disease that can be specifically attributed to the drug are nausea and vomiting of mild grade in approximately 25% of patients, and low-grade elevation of creatinine also in approximately 25% of patients. A further disadvantage of miltefosine is that regimens shorter than 4 weeks have not been evaluated for cutaneous disease.

Combination therapy is now being used for many infectious diseases, such as tuberculosis, malaria, and HIV. Combination therapy offers the potential of preventing drug resistance, because organisms resistant to one of the drugs may be susceptible to the other drug; and also the potential to diminish drug therapy duration and thus side effects. These two potential benefits to some extent contradict each other: preventing resistance is best done if full courses of both drugs is used; diminishing therapy duration means using less than the full course of each drug. The optimum combination regimen is one in which sufficient amounts of both drugs are used to have high efficacy, yet the amounts are as low as possible to spare patients unnecessarily long courses of drug.

In the present protocol, the combination of a half-course of miltefosine and a half-course of antimony will be evaluated for efficacy and tolerance. The combination of miltefosine and antimony is chosen because these are now the two standard agents in Bolivia, and in vitro the combination was additive to mildly synergistic against a standard leishmania strain.


Recruitment information / eligibility

Status Terminated
Enrollment 19
Est. completion date January 2009
Est. primary completion date August 2008
Accepts healthy volunteers No
Gender Both
Age group 12 Years to 75 Years
Eligibility Inclusion Criteria:

- Parasitological confirmation

- at least 1 lesion must be ulcerative

- No specific antileishmanial therapy during the previous six months

Exclusion Criteria:

- Concomitant diseases such as Tuberculosis, HIV, diabetes, renal failure, liver disease

- abnormalities CTC 2 in blood, liver, kidney test or EKG

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Miltefosine and antimony
Short course (half of each drug) administered simultaneously
Miltefosine alone
short course (half)

Locations

Country Name City State
Bolivia Hospital Local La Paz

Sponsors (2)

Lead Sponsor Collaborator
Foundation Fader AB Foundation

Country where clinical trial is conducted

Bolivia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Healing of ulcers 45 days Yes
Secondary Clinical findings and Laboratory parameters in normal ranges 28 days Yes
See also
  Status Clinical Trial Phase
Completed NCT01988909 - WR 279,396 for 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
Enrolling by invitation NCT00840359 - Study of the Efficacy of Daylight Activated Photodynamic Therapy in the Treatment of Cutaneous Leishmaniasis Phase 2
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
Terminated NCT00317629 - Controlled Nitric Oxide Releasing Patch Versus Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis Phase 3
Completed NCT00351520 - Efficacy Trial on Oral Miltefosine in Comparison With Glucantime in the Treatment of ACL Caused by L. Tropica 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
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
Completed NCT03023111 - Miltefosine and GM-CSF in Cutaneous Leishmaniasis Phase 3