Add-on Study of Pentoxifylline in Cutaneous Leishmaniasis

NCT01464242 | Completed Phase 2 DMC

• 1 other identifier: 222951928964
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether adding pentoxifylline to treatment of American cutaneous leishmaniasis with meglumine antimoniate increases the rate and speed of clinical response without diminishing safety, and to identify immune correlates of the healing response.

Conditions

Cutaneous Leishmaniasis

Keywords

Cutaneous Leishmaniasis; pentoxifylline; immunomodulation

Outcome Measures

Primary Outcomes (2)

• Primary efficacy outcome: Definitive Cure

  Definitive cure, defined as complete re-epithelialization and absence of inflammatory signs in all cutaneous leishmaniasis lesions, and absence of new leishmaniasis lesions

  Participants will be followed up to 26 weeks

• Primary safety outcome: Adverse Events

  Clinical and laboratory adverse events will be qualified according to the Common Toxicity Criteria for Adverse Effects (CTCAE). All unexpected non serious adverse events will be notified and expected adverse events of moderate or higher category will be reported. All serious adverse events will be reported.

  Participants will be followed up to 26 weeks

Secondary Outcomes (4)

• In vitro lymphoproliferation

  Participants will be followed for an average of 20 days

• Cytokine secretion by PBMCs

  Participants will be followed for an average of 20 days

• Macrophage leishmanicidal capacity

  Participants will be followed for an average of 20 days

• Macrophage inducible nitric oxide synthase (iNOS) expression

  Participants will be followed for an average of 20 days

Study Arms (2)

Glucantime® + pentoxifylline

EXPERIMENTAL

Glucantime® 20mg/kg/day intramuscular injection (IM) daily for 20 days + pentoxifylline 400mg orally 3 times a day for 20 days.

Drug: Meglumine antimonate; Drug: Pentoxifylline

Glucantime® + placebo

PLACEBO COMPARATOR

Glucantime® 20mg/kg/day IM each day for 20 days + placebo 400mg orally 3 times a day for 20 days.

Drug: Meglumine antimonate; Drug: Placebo

Interventions

Meglumine antimonate DRUG

Glucantime® 20mg/kg/day IM daily for 20 days

Also known as: Glucantime ®

Glucantime® + pentoxifylline; Glucantime® + placebo

Placebo DRUG

Placebo 400mg orally 3 times a day for 20 days

Glucantime® + placebo

Pentoxifylline DRUG

Pentoxifylline 400mg orally 3 times a day for 20 days

Glucantime® + pentoxifylline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with clinical diagnosis of cutaneous leishmaniasis (parasitologic confirmation or presumptive biopsy plus a positive Montenegro skin test).
• Age between 18 and 65 years.
• Lesions of a duration equal to or greater than one month
• More than one lesion or single lesion greater than 3 cm in diameter.
• Willingness to participate in the study after being informed through a consent process approved by the institutional ethical review committee

You may not qualify if:

• Pregnant or lactating women, and women who are planning to conceive during the study or that reject the use of birth control methods.
• Medical conditions that compromise the immune system (HIV infection, neoplasias, diabetes mellitus, autoimmune diseases, or use of corticosteroids, immunomodulators or antineoplastic drugs).
• Medical conditions that preclude the use of antimonials or pentoxifylline (cardiac, renal, hepatic or pancreatic disease or abnormalities).
• Alcohol abuse or use of recreational drugs that interfere with adherence to treatment
• Use of drugs with antileishmanial potential during the previous 13 weeks, including pentavalent antimonials, amphotericin B, miltefosine, and pentamidine
• Use of Theophylline , anticoagulants or antiarrhythmics.
• Diffuse or disseminated leishmaniasis.
• Mucosal involvement secondary to Leishmania infection.
• Incapacity to attend the study visits or any other condition that according to the investigator could interfere with adherence to study procedures.

Sponsors & Collaborators

• Centro Internacional de Entrenamiento e Investigaciones Médicas: lead

Study Sites (1)

Corporación Centro Internacional de entrenamiento e Investigaciónes Médicas

Cali, Valle del Cauca Department, 5930, Colombia

Location

Related Publications (1)

• Castro MDM, Cossio A, Velasco C, Osorio L. Risk factors for therapeutic failure to meglumine antimoniate and miltefosine in adults and children with cutaneous leishmaniasis in Colombia: A cohort study. PLoS Negl Trop Dis. 2017 Apr 5;11(4):e0005515. doi: 10.1371/journal.pntd.0005515. eCollection 2017 Apr.

  PMID: 28379954 DERIVED

MeSH Terms

Conditions

Leishmaniasis, Cutaneous

Interventions

Meglumine Antimoniate; Pentoxifylline

Condition Hierarchy (Ancestors)

Leishmaniasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Skin Diseases, Parasitic; Vector Borne Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Meglumine; Sorbitol; Sugar Alcohols; Alcohols; Organic Chemicals; Hexosamines; Amino Sugars; Carbohydrates; Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Nancy C Saravia, PhD

  Centro Internacional de Entrenamiento e Investigación Médica

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2011
• First Posted: November 3, 2011
• Study Start: November 1, 2011
• Primary Completion: January 1, 2015
• Study Completion: December 1, 2015
• Last Updated: August 23, 2016

Record last verified: 2016-08

Locations

CO (1)