Clinical trial comparing two medicines for the treatment of verruga Peruana

• Register: ISRCTN
• Last refreshed on: 8 May 2023
• Main ID: ISRCTN16597283
• Date of registration: 11/03/2016
• Prospective Registration: No
• Primary sponsor: Uniformed Services University of the Health Sciences
• Public title: Clinical trial comparing two medicines for the treatment of verruga Peruana
• Scientific title: A randomized controlled treatment trial for the verrucous stage of Bartonella bacilliformis infection in Peru
• Date of first enrolment: 16/06/2003
• Target sample size: 127
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN16597283
• Study type: Interventional
• Study design: Community-based randomised parallel trial (Treatment)
• Phase: Phase III/IV

Countries of recruitment

Peru

Contacts

• Name: David Blazes

Key inclusion & exclusion criteria

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
Exclusion criteria: 1. Pregnancy
2. Use of oral contraceptives
3. Breast-feeding
4. Admission to the hospital for an unrelated condition
5. Use of antibiotics within the month preceding potential enrollment in the trial
6. Chronic use of alcohol
7. Known chronic liver disease
8. Use of medications that potentially interact with rifampin or azithromycin during the study period

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Bartonella bacilliformis infection
Infections and Infestations
Bartonella bacilliformis infection

Intervention(s)

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.

Primary Outcome(s)

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(s)

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

Secondary ID(s)

G187OG-01

Source(s) of Monetary Support

Uniformed Services University of the Health Sciences, Pfizer

Ethics review

Status:
Approval date:
Contact:

1. Naval Medical Research Center, 28/06/2001, ref: FWA-00000152 2. Services University of the Health Sciences, 12/04/2001, ref: FWA-00001628 3. Peruvian University Cayetano Heredia, 04/09/2001, ref: FWA-00000525

Results

• Results available: Yes
• Date Completed: 30/03/2004