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Supportive Care With Delayed Versus Immediate Antibiotics for Uncomplicated Upper Respiratory Tract Infection Among Corps Members in Paiko, Niger State: A Pragmatic Randomized Trial

Supportive Care With Delayed Versus Immediate Antibiotics for Uncomplicated Upper Respiratory Tract Infection Among Corps Members in Paiko, Niger State: A Pragmatic Randomized Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202604778255006
Enrollment
128
Registered
2026-04-24
Start date
2025-10-05
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

Respiratory

Interventions

Immediate antibiotics plus supportive care
Supportive care with delayed antibiotic strategy

Sponsors

None
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - NYSC Corps Members presenting with uncomplicated URTI, defined as a short illness (lasting five days or less) characterised by symptoms such as sore throat, runny nose, nasal congestion, cough, or mild fever (temperature up to 38.5°C). - Participants had to be clinically stable with normal findings on chest examination, no warning signs, and stable vital signs, and they had to be able to provide consent and agree to follow-up.

Exclusion criteria

Exclusion criteria: - Clinical features suggesting complicated or high-risk infection requiring immediate antibiotics or higher-level care, including suspected pneumonia, severe exudative tonsillitis with high fever, respiratory distress, temperature exceeding 38.5°C, or significant dehydration. - Significant chronic respiratory or systemic illness such as asthma, COPD, or uncontrolled diabetes that could alter the course of URTI or increase risk. - Known immunocompromised status, including HIV or current immunosuppressive therapy. - Known allergy or contraindication to the study antibiotic. - Ongoing antibiotic treatment for the current illness or another concomitant infection requiring antibiotics. - Any other condition that, in the clinician’s judgement, made a delayed-antibiotic approach unsafe.

Design outcomes

Primary

MeasureTime frame
Clinical recovery by Day 5, defined as complete symptom resolution with total symptom score of 0 at Day 5.

Secondary

MeasureTime frame
- Complete symptom resolution at Day 3 - Where available, complete symptom resolution at Day 7 for participants still symptomatic at Day 5 - Antibiotic use within the first five days - Occurrence of complications or adverse outcomes, including suspected bacterial complications, prolonged or worsening illness requiring additional treatment, referrals, or hospitalisation - Adverse drug reactions attributed to antibiotics, such as gastrointestinal upset, rash, or allergic reactions

Countries

Nigeria

Contacts

Public ContactChukwugemezu Ihechere
m.ihechere1@gmail.com+2349153549419

Outcome results

None listed

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