A study to compare different injectable antibiotic treatments and different modes of fluid treatment for children with severe pneumonia.

Phase 3

• Conditions: Paediatrics

• Registration Number: PACTR202106720981298
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-18
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 4392

Inclusion Criteria

•Age 2 to 59 months.
•History of cough or difficulty breathing and signs of severe pneumonia based on WHO 2013 criteria
•Admitted to any one of the study hospitals.
•Informed consent provided by the parents/guardian.

Exclusion Criteria

•Children presenting in cardiorespiratory arrest requiring emergency basic life support (bag-valve-mask ventilation and/or chest compressions).
•Children for whom concurrent condition precludes the use of the first-line antibiotics for severe pneumonia such as readmission or meningitis
•Shock due to dehydration or severe dehydration (based on WHO definitions (5)) requiring emergency fluid resuscitation
•Known allergy or contraindication to penicillin, gentamicin, ceftriaxone or amoxicillin-clavulanic acid.
•Referral from another inpatient facility following treatment with injectable antibiotics for more than 24 hours or because the first-line regimen is considered to have failed
•Previously enrolled in the study.
•For Randomisation 2 (IV fluid versus nasogastric feeds): children with absent gag reflex.
•For Randomisation 2 (IV fluid versus nasogastric feeds): children unable to maintain oxygen saturations ?90% on pulse oximetry while receiving supplemental oxygen.
•For Randomisation 2 (IV fluid versus nasogastric feeds): children with severe acute malnutrition

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality<br>Mortality of participants receiving any of the injectable antibiotic treatments who die within the first five days of admission. ;Mortality<br>Mortality of participants receiving any of the supportive care treatments who die within the first five days of admission.

Secondary Outcome Measures

Name	Time	Method
umber of serious adverse events defined as serious adverse events that may be likely or definitely related to any of the interventions given to the participants. Serious adverse events include death, a life threatening event, persistent or significant disability or incapacity, hospitalisation or prolonged hospitalisation.;Length of hospitalisation defined as the total days a participant is admitted or receives inpatient care measured in days using hospital records at the start and end of each admission;Duration taken to tolerate full fluids by mouth defined as the number of days it takes for participants to fully tolerate fluids orally;Mortality 30 days after enrollment defined as the number of participants who die within 30 days of enrollment into the study.