Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202604778255006 Date of Registration: 24/04/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Supportive Care With Delayed Versus Immediate Antibiotics for Uncomplicated Upper Respiratory Tract Infection Among Corps Members in Paiko, Niger State: A Pragmatic Randomized Trial
Official scientific title Supportive Care With Delayed Versus Immediate Antibiotics for Uncomplicated Upper Respiratory Tract Infection Among Corps Members in Paiko, Niger State: A Pragmatic Randomized Trial
Brief summary describing the background and objectives of the trial A pragmatic randomized trial among NYSC Corps Members in Paiko, Niger State, that compares supportive care plus a delayed antibiotic prescription to immediate antibiotic therapy for uncomplicated URTIs. The primary objective is to determine whether supportive care with delayed antibiotics achieves clinical improvement by Day 5 compared to immediate antibiotics. Secondary objectives are to compare (1) the proportion of participants in each group who actually take antibiotics within the first 5 days of illness, and (2) the occurrence of complications, adverse events, or unplanned medical visits in the two groups.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 05/10/2025
Actual trial start date 05/10/2025
Anticipated date of last follow up 12/10/2025
Actual Last follow-up date 12/10/2025
Anticipated target sample size (number of participants) 128
Actual target sample size (number of participants) 128
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Immediate antibiotics plus supportive care Amoxicillin 500 mg orally three times daily; alternative: erythromycin 500 mg orally twice daily if penicillin allergy/contraindication. Supportive care as needed: paracetamol, throat lozenges, cough syrup, rest, oral fluids, vitamin C. 5 days Participants received immediate oral antibiotics at enrolment plus supportive care tailored to symptoms. The standard antibiotic regimen was amoxicillin 500 mg three times daily for 5 days, or erythromycin 500 mg twice daily for 5 days where penicillin allergy or another contraindication existed. Supportive care could include paracetamol, throat lozenges, cough syrup, rest, adequate oral fluids, and vitamin C supplementation. Participants were reviewed on Day 3 and Day 5. 58
Control Group Supportive care with delayed antibiotic strategy Supportive care at enrolment as needed: paracetamol, throat lozenges, cough syrup, rest, adequate oral fluids, and vitamin C supplementation. Antibiotics only if symptoms did not improve or worsened at Day 3 review: amoxicillin 500 mg orally three times daily, or erythromycin 500 mg orally twice daily if penicillin allergy or contraindication existed. Supportive care from enrolment to Day 5 follow-up. If antibiotics were started, antibiotic course lasted 5 days. Participants received supportive care only at enrolment and were not given antibiotics initially. They were reviewed on Day 3 and Day 5. At Day 3, participants whose symptoms had not improved or had worsened were started on oral amoxicillin 500 mg three times daily for 5 days, or oral erythromycin 500 mg twice daily for 5 days if penicillin allergy or another contraindication existed. Participants who improved did not receive antibiotics. No back-up prescription was given at enrolment; antibiotic initiation required clinical re-evaluation at the camp clinic. 70 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- 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. - 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. Adult: 18 Year(s)-44 Year(s) 18 Year(s) 30 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 02/10/2025 Health Research Ethics Committee Ahmadu Bello University Teaching Hospital
Ethics Committee Address
Street address City Postal code Country
Shika Zaria 810105 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Clinical recovery by Day 5, defined as complete symptom resolution with total symptom score of 0 at Day 5. Day 5
Secondary Outcome - 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 Day 3, Day 5, Day 7
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
NYSC Orientation Camp Clinic Paiko, Niger State Paiko 920103 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Ihechere Chukwugemezu Ephrem NYSC Orientation Camp Clinic Paiko 920103 Nigeria
NYSC Orientation Camp Clinic NYSC Permanent Orientation Camp Paiko 920103 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor None Not applicable Not applicable NA Nigeria Not applicable
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Chukwugemezu Ihechere m.ihechere1@gmail.com +2349153549419 Emerald garden estate
City Postal code Country Position/Affiliation
Abuja 900107 Nigeria NA
Role Name Email Phone Street address
Public Enquiries Chukwugemezu Ihechere m.ihechere1@gmail.com +2349153549419 Emerald estate
City Postal code Country Position/Affiliation
Abuja 900107 Nigeria NA
Role Name Email Phone Street address
Scientific Enquiries Chukwugemezu Ihechere m.ihechere1@gmail.com +2349153549419 Emerald Estate
City Postal code Country Position/Affiliation
Abuja 900107 Nigeria NA
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes No individual participant data will be shared Informed Consent Form Not applicable. Not applicable.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 14/04/2026 A typographical error was made. The target number of participants was 130. 120 130
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 14/04/2026 A typographical error was made 130 128
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 14/04/2026 This wasn't included in the first submission. This did not get up to the target number because 2 revoked their participation. 128
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 14/04/2026 A mistake on my part, my apologies. TRUE, Health Research Ethics Committee Ahmadu Bello University Teaching Hospital , Shika, Zaria, 810105, Nigeria, , 02 Apr 2026, +2347044404469, info@abuth.gov.ng, 39640_38422_4737.pdf TRUE, Health Research Ethics Committee Ahmadu Bello University Teaching Hospital , Shika, Zaria, 810105, Nigeria, , 02 Oct 2025, +2347044404469, info@abuth.gov.ng, 39640_38422_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 15/04/2026 Named investigator Self funded by investigators, NYSC Orientation Camp Clinic, Paiko, 920103, Nigeria, Self Funded, Ihechere Chukwugemezu Ephrem, NYSC Orientation Camp Clinic, Paiko, 920103, Nigeria, Self Funded,