TREATMENT OF LESHMANIASIS CUTAENA PERUANA WITH PENTAMIDINE ISETIONATE (WR 179745) USING MEGLUMIN ANTIMONIATE AS A POSITIVE CONTROL: A PHASE III B STUDY
- Conditions
- -B55 LeishmaniasisLeishmaniasisB55
- Registration Number
- PER-057-00
- Lead Sponsor
- IVERSIDAD PERUANA CAYETANO HEREDIA,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• Be able to give written consent. Written consent will be signed as soon as the prospective volunteer shows a reasonable understanding of the study, its risks and benefits and its role, after the principal investigator or designated study member has provided a full explanation. The volunteer can ask any question. The written consent will be in Spanish or Quechua, whatever the language the volunteer can understand. The volunteer can keep a copy of the consent.
• Availability to meet the study schedule
•Good health
• Age: 18-60 years of age
• Parasitological diagnosis: having cutaneous leishmaniasis parasitologically proven in the lesion.
• Intolerance to the drug. History of known or suspected hypersensitivity or idiosyncratic reactions to pentamidine Pentostam® or Pentacarianato®, meglumine antimonate, Glucantime®, sodium stibogluconate or Pentostam®
• Previous use of antileishmanial drugs
• Current use of nephrotoxic drugs, which induce pancreatitis or hypoglycemics on a routine basis, list presented in Appendix 1.
• Previous history of leishmaniasis confirmed on the basis of a clinically compatible history (due to a previous scar)
• Potential for follow-up: that can not be followed for 8 months.
• Concomitant medical problems: significant medical problems of the kidney, pancreas or impaired glucose control as determined by laboratory and background studies. Volunteers in whom these normal laboratory values do not exceed more than 25% are not automatically excluded. These volunteers will be evaluated based on their background, and both physical and laboratory values.
• Any acute medical or psychiatric condition that may increase the risks associated with participation in the study or interfere with the interpretation of study results in the opinion of the treating researcher: patients with systemic disease, such as TB diagnosed by pulmonary radiography or presence of bacilli (acid fast) in colored sputum smears.
• Pregnancy or lactation: any woman who is pregnant or breastfeeding will not be able to enter the clinical study. Women of childbearing age and capacity will not be able to participate in the study unless they agree to avoid sexual activity during the drug treatment period, plus 2 weeks.
• Evidence of mucosal involvement in the oropharynx.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Clinical parameter; lesions will be measured in two perpendicular directions and photographs will be taken.<br>Parasitological parameter: aspiration and scraping of the lesion will be repeated. The initial lesion may be investigated and others, if clinically required.<br>Measure:Efficacy<br>Timepoints:Clinical parameter; before the therapy and on the following dates after the end of the therapy: at half month, at 3 months and at 6 months.<br>Parasitological parameter: 2 weeks after the end of treatment if the lesion is not 100% re-epithelialized.<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:General clinical history, physical examination, EKG, CBC, CA, Mg, K, AST, ALT Alk, Fos, Bili, Creatinine, HCG Lipase<br>Measure:Safety<br>Timepoints:The physical examination will be performed on each treatment and the other parameters on days 0, 4, 8, 12.<br>