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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Syed Hasan
Principal investigator, Scientific

Huddersfield University
Huddersfield
HD1 3DH
United Kingdom

ORCiD logoORCID ID 0000-0002-4058-2215
Phone ‪+44 1484 256941
Email s.hasan@hud.ac.uk
Mrs Walaa Elmeniar
Public, Scientific

Huddersfield University
Huddersfield
HD1 3DH
United Kingdom

ORCiD logoORCID ID 0009-0004-7768-3097
Phone +44 7438930854
Email Walaa.Elmenir@hud.ac.uk
Prof Hafez Bazarra
Principal investigator, Scientific

Cairo University
Cairo
12613
Egypt

ORCiD logoORCID ID 0000-0002-4893-9274
Phone +20 1222235316
Email hmbazaraa@kasralainy.edu.eg

Study information

Primary study designInterventional
AllocationRandomized controlled trial
MaskingOpen (masking not used)
ControlActive
AssignmentParallel
PurposeTreatment
Scientific titleClinical 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) studiedHospitalised children with mild to moderate infections requiring antimicrobial therapy
Intervention64 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 typeProcedure/Surgery
Primary outcome measure(s)
  1. Duration of IV and PO antibiotic therapy (days) measured using Medical record review at Baseline, day of eligibility of IV-to-PO switch, during the 7 days after conversion, day 14 follow-up
  2. Total antibiotic duration (days) measured using Medical record review at Baseline, day of eligibility of IV-to-PO switch, during the 7 days after conversion, day 14 follow-up
  3. Length of hospital stay (days) measured using Hospital administrative records at Baseline, day of eligibility of IV-to-PO switch, day 14 follow-up
  4. Treatment success rate measured using Clinical assessment documented in medical records at Day of eligibility of IV-to-PO switch, during the 7 days after conversion, day 14 follow-up
  5. Rate of antibiotic-related adverse events measured using Adverse event reporting in medical records at Baseline, during the 7 days after conversion, day 14 follow-up
  6. Rate of recurrence within 14 days measured using Clinical assessment documented in medical records at Day 14 follow-up
  7. Rate of reconverted patients to IV therapy measured using Medical record review at During the 7 days after conversion, day 14 follow-up
Key secondary outcome measure(s)
Completion date08/04/2027

Eligibility

Participant type(s)
Age groupMixed
Lower age limit1 Month
Upper age limit14 Years
SexAll
Target sample size at registration64
Key inclusion criteria1. 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 criteria1. 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 enrolment20/06/2026
Date of final enrolment08/04/2027

Locations

Countries of recruitment

  • Egypt

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to shareNo

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.