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