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