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Clinical trial comparing two medicines for the treatment of verruga Peruana

A randomized controlled treatment trial for the verrucous stage of Bartonella bacilliformis infection in Peru

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN16597283
Enrollment
127
Registered
2016-03-11
Start date
2003-06-16
Completion date
Unknown
Last updated
2023-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bartonella bacilliformis infection Infections and Infestations Bartonella bacilliformis infection

Interventions

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: Adul

Sponsors

Uniformed Services University of the Health Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Peru

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026