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

Clinical efficacy and safety of early intravenous-to-oral antimicrobial conversion versus continued intravenous therapy in hospitalised pediatric patients with mild to moderate infections

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN11435073

Enrollment

Registered

2026-06-23

Start date

2026-06-20

Completion date

Unknown

Last updated

2026-07-13

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

Conditions

Hospitalised children with mild to moderate infections requiring antimicrobial therapy Infections and Infestations

Interventions

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

Eligibility

Sex/Gender

All

Age

1 Months to 14 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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;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;Length of hospital stay (days) measured using Hospital administrative records at Baseline, day of eligibility of IV-to-PO switch, day 14 follow-up;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;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;Rate of recurrence within 14 days measured using Clinical assessment documented in medical records at Day 14 follow-up;Rate of reconverted patients to IV therapy measured using Medical record review at During the 7 days after conversion, day 14 follow-up	—

Measure

Time frame

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;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;Length of hospital stay (days) measured using Hospital administrative records at Baseline, day of eligibility of IV-to-PO switch, day 14 follow-up;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;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;Rate of recurrence within 14 days measured using Clinical assessment documented in medical records at Day 14 follow-up;Rate of reconverted patients to IV therapy measured using Medical record review at During the 7 days after conversion, day 14 follow-up

—

Countries

Egypt

Contacts

Public ContactWalaa Elmeniar

Walaa.Elmenir@hud.ac.uk+44 7438930854

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jul 23, 2026