Can children in hospital safely switch from antibiotics given through a vein to antibiotics taken by mouth? A study to assess whether this approach is practical, effective, and can reduce hospital stay and treatment costs in Egypt
| ISRCTN | ISRCTN11435073 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11435073 |
| Sponsor | Cairo University hospitals |
| Funder | Cairo University Hospitals |
- Submission date
- 19/06/2026
- Registration date
- 23/06/2026
- Last edited
- 23/06/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Infections and Infestations
Plain English summary of protocol
Not provided at time of registration
Contact information
Principal investigator, Scientific
Huddersfield University
Huddersfield
HD1 3DH
United Kingdom
| 0000-0002-4058-2215 | |
| Phone | +44 1484 256941 |
| s.hasan@hud.ac.uk |
Public, Scientific
Huddersfield University
Huddersfield
HD1 3DH
United Kingdom
| 0009-0004-7768-3097 | |
| Phone | +44 7438930854 |
| Walaa.Elmenir@hud.ac.uk |
Principal investigator, Scientific
Cairo University
Cairo
12613
Egypt
| 0000-0002-4893-9274 | |
| Phone | +20 1222235316 |
| hmbazaraa@kasralainy.edu.eg |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Open (masking not used) |
| Control | Active |
| Assignment | Parallel |
| Purpose | Treatment |
| Scientific title | Clinical efficacy and safety of early intravenous-to-oral antimicrobial conversion versus continued intravenous therapy in hospitalised pediatric patients with mild to moderate infections |
| Study objectives | |
| Ethics approval(s) |
1. Approved 09/04/2026, Cairo University, Faculty of Medicine, Research Ethics Commitee (Kasr Al Aini, Cairo University, Cairo, 12613, Egypt; +20 2 35674835; kasralainyrec@kasralainy.edu.eg), ref: N-63-2026 2. Approved 05/06/2026, Huddersfield University, School of Applied Sciences Research Integrity and Ethics Committee (School of Applied Sciences, University of Huddersfield, Queensgate, Huddersfield, HD1 3DH, United Kingdom; +44 1484422288; sas_ethics@hud.ac.uk), ref: SAS-SRIEC-05.06.2026WE_2 |
| Health condition(s) or problem(s) studied | Hospitalised children with mild to moderate infections requiring antimicrobial therapy |
| Intervention | 64 patients will be randomized & allocated using a computer-generated random sequence (1:1 ratio) and randomized to groups. Sealed opaque envelopes will be used. The CONSORT study flow diagram will be used. Control arm: Continue the whole treatment duration with IV antibiotics, if indicated. This is the standard treatment in EGYPT. Study arm: Convert antibiotics from IV to PO dosage form if antibiotics are still indicated and the patient is a candidate for IV to PO conversion. This is the WHO and CDC recommendation as an antimicrobial stewardship intervention. Data will be collected from day 1 of admission and followed up every 24 hours using a designed data collection sheet. The patient will be followed up till discharge or at least 5 days, starting from the date the patient is eligible for the conversion. Efficacy and safety of IV to PO antimicrobial conversion are the primary outcomes. Length of hospital stay, rate of re-admission of re-converted patients. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) | |
| Completion date | 08/04/2027 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 1 Month |
| Upper age limit | 14 Years |
| Sex | All |
| Target sample size at registration | 64 |
| Key inclusion criteria | 1. Age more than 1 month to 14 years of both sexes 2. Hospitalised patients with proven infection (community-acquired pneumonia (non-invasive ventilated patients) and uncomplicated urinary tract infection) 3. Requiring initiation and continuation of antimicrobials 4. Patient is vitally and hemodynamically stable 5. Afebrile for ≥24 hours 6. Tolerate enteral feeds and take medications orally |
| Key exclusion criteria | 1. Patients with GI disorders (e.g., obstruction, malabsorption, active GI bleeding, nothing by mouth (NPO), short gut syndrome, and continuous feeds that cannot be held if the antimicrobial agent has a food interaction) 2. CNS Disorders: seizures and risk of aspiration 3. Hemodynamic instability: hypotension or shock 4. Patients refusing oral medication 5. Febrile neutropenia < 1000 cells/mm³ or functional asplenia 6. Severe infection or deep-seated infection (e.g., meningitis, endocarditis, deep abscess, initiation of treatment in bone and joint infections, infected prosthesis) 7. Antibiotics are used as surgical prophylaxis |
| Date of first enrolment | 20/06/2026 |
| Date of final enrolment | 08/04/2027 |
Locations
Countries of recruitment
- Egypt
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 19/06/2026 | No | No |
Additional files
- 49750 Protocol.pdf
- Protocol file
Editorial Notes
19/06/2026: Trial's existence confirmed by Huddersfield University, School of Applied Sciences Research Integrity and Ethics Committee.