Clinical trial comparing two medicines for the treatment of verruga Peruana

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2016
INTERVENTION: Participants are randomly allocated to one of two groups using random computer generation of a scheme, blocked in groups of ten to ensure similar numbers will be assigned to each group. Group 1: Adult participants receive Rifamin for two weeks at a dose of 600mg PO daily, Ch receild participants receive 10mg/kg daily (not to exceeding 600mg PO daily). Group 2: Azithromycin .s administered once weekly for two weeks (which gives effective tissue levels for two weeks). Adults receive a 1.0 gram PO dose at Day 0 and Day 8 and children receive a 20mg/kg PO dose at Day 0 and Day 8 (not to exceed standard adult doses as above). For both groups, liquid elixirs are provided for children less than eight years of age, with tablets for all patients older than eight years. Participants in both groups are followed up after 7, 14, 30 and 60 days. CONDITION: Bartonella bacilliformis infection ; Infections and Infestations ; Bartonella bacilliformis infection PRIMARY OUTCOME: 1. Time to resolution of verrucous lesions is measured from photographs and physical examinations undertaken at baseline, 7, 14, 30 and 60 days; 2. Time to resolution of Bartonella bacteremia is measured through blood culture and PCR undertaken at baseline, 7, 14, 30 and 60 days SECONDARY OUTCOME: 1. Risk factors for Bartonella bacteremia measured using a questionnaire at baseline; 2. Characteristics for clinical and laboratory findings associated with rash and Bartonella bacteremia measured at baseline, 7, 14, 30 and 60 days; INCLUSION CRITERIA: 1. Aged between 1 and 60 years 2. Clinical presentation compatible with Verruga peruana (chronic verrucous stage of Bartonellosis) 3. Able to provide informed consent/parental informed consent for children
Epistemonikos ID: 9db9418935cc89f35e74d9c080d9853c0d3ae197
First added on: Aug 24, 2024