Overview

A Study to Compare Different Antibiotics and Different Modes of Fluid Treatment for Children With Severe Pneumonia

Status:
Suspended
Trial end date:
2023-02-01
Target enrollment:
0
Participant gender:
All
Summary
Pneumonia is one of the top causes of death in children aged below 5. More than 10% of children with severe pneumonia die. We are not sure that the currently recommended antibiotics used in children with pneumonia are the most effective. No studies have been carried out to find out whether children with pneumonia should be given intravenous (IV) fluids or nasogastric (NG) feeds. The SEARCH trial aims to find out which antibiotics and modes of feeding are the most effective in treating children with severe pneumonia and therefore helping reduce mortality.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Oxford
Collaborators:
Department for International Development, United Kingdom
Kenya Ministry of Health
London School of Hygiene and Tropical Medicine
Medical Research Council
National Institute for Health Research, United Kingdom
University of Nairobi
Wellcome Trust
Treatments:
Amoxicillin
Amoxicillin-Potassium Clavulanate Combination
Ampicillin
Anti-Bacterial Agents
Antibiotics, Antitubercular
Ceftriaxone
Clavulanic Acid
Clavulanic Acids
Gentamicins
Penicillin G
Penicillin G Benzathine
Penicillin G Procaine
Penicillins
Criteria
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 supportive care intervention (Intravenous fluids versus nasogastric feeds):
children with absent gag reflex.

- For supportive care intervention (Intravenous fluids versus nasogastric feeds):
children unable to maintain oxygen saturations greater 90% on pulse oximetry while
receiving supplemental oxygen.

- For supportive care intervention (Intravenous fluids versus nasogastric feeds):
children with severe acute malnutrition