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Oral Azithromycin Versus Intramuscular Penicillin for Secondary Prevention of Rheumatic Heart Disease in Nigerian Secondary School Students: A Comparative Study to Improve Outcomes in Rheumatic Heart Disease Management)

Improving Management and Prevention through Azithromycin Comparative Trial in Rheumatic Heart disease- IMPACT-RHD Nigeria Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202605528662643
Enrollment
474
Registered
2026-05-19
Start date
2027-01-03
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Circulatory System Group A beta Haemolytic Sptreptococcal Organisms and teh Heart Cardiology

Interventions

Intramuscular Benzathine penicillin

Sponsors

Akintunde Adeseye Abiodun
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: -Enrolled in one of the selected secondary schools within proximity to the tertiary hospitals, -They must have a confirmed diagnosis of mild or moderate RHD. -They must be capable of attending monthly visits. -At enrollment, students must demonstrate cognitive capacity to assent. - Female students of childbearing potential must agree to avoid pregnancy during the trial. -The individual must not have initiated any alternative RHD prophylaxis regimen before enrollment

Exclusion criteria

Exclusion criteria: -Students with advanced RHD (Stage C or D) that requires immediate surgical or intensive clinical management rather than secondary prophylaxis. - known allergy to penicillin or any history of anaphylaxis to antibiotics. -Students with severe comorbidities likely to complicate prophylaxis or follow-up, e.g., kidney or liver disease, uncontrolled diabetes, or other serious chronic illnesses (e.g., active tuberculosis, immunodeficiency) - Students with cognitive impairment that preclude assent or reliable adherence. - Any student currently enrolled in another interventional trial, or who is or whose parents are unwilling or unlikely to comply with monthly visits.

Design outcomes

Primary

MeasureTime frame
The primary outcome of the study will be the proportion of participants in the oral antibiotics arm who progress to more advanced RHD compared to those in the BPG arm post intervention.

Secondary

MeasureTime frame
Secondary outcomes are patient-reported outcomes (treatment acceptance, satisfaction, and health-related quality of life using Health Related Quality of Life Questionnaire, HRQoL), costs, and cost-effectiveness of oral antibiotics compared to intramuscular penicillin prophylaxis for RHD post intervention.

Countries

Nigeria

Contacts

Public ContactAgnes Inyam

Research Officer. Dept of Physiology LAUTECH Ogbomoso

inyamagnes466@gamil.com2348133622392

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026