NCT04041791

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

Supportive Care and Antibiotics for Severe Pneumonia Among Hospitalized Children (SEARCH): A Pragmatic Randomised Controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4,392 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 2 Months – 59 Months
• Healthy volunteers: Not accepted

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.

Detailed description

Pneumonia is one of the leading causes of death among young children with more than 10% of children aged under-five with severe pneumonia dying. The World Health Organisation (WHO) guidelines recommend the use of benzyl penicillin plus gentamicin as the standard of care of treatment for severe pneumonia. However, there have been increasing concerns about the effectiveness of the current recommendations. Some authorities advise against the use of enteral nutrition in severely ill patients due to concerns of compromised respiratory status and risk of aspiration with nasogastric feeding. Evidence to support these concerns is lacking. This trial aims to find out which antibiotics are the most effective in the treatment of children with severe pneumonia by comparing the current standard of care (benzyl penicillin or ampicillin plus gentamicin) to injectable ceftriaxone and injectable amoxicillin-clavulanic acid. The study will also determine whether providing feeds through a nasogastric tube is superior to intravenous fluid therapy in children with severe pneumonia. The SEARCH trial will be a multi-site pragmatic randomised controlled trial that will assess the efficacy of both interventions in children admitted with severe pneumonia in a 3x2 factorial design. The sites will be in East Africa. Data from the trial will be used to inform policy and contribute to guidelines and improve clinical practice in settings where the burden of pneumonia is highest.

Conditions

• Pneumonia

Interventions

Type	Name	Description
DRUG	Benzyl penicillin	Benzyl penicillin is a penicillin antibiotic.
DRUG	Gentamicin Sulfate	Gentamicin is an aminoglycoside antibiotic.
DRUG	Ceftriaxone	Ceftriaxone is a third generation cephalosporin antibiotic active against a wide range of gram negative and positive bacteria.
DRUG	Amoxicillin Clavulanate	Amoxicillin Clavulanate is a combination of amoxicillin, a β-lactam antibiotic, and potassium clavulanate, a β-lactamase inhibitor.
OTHER	Intravenous fluid	Maintenance fluids administered for at least 24 hours.
OTHER	Nasogastric feeds	Feeds given via nasogastric tube. Feeds may include cow's milk, breast milk, porridge, formula among others.
DRUG	Ampicillin	Ampicillin is a penicillin-type antibiotic.

Timeline

• Start date: 2019-08-19
• Primary completion: 2024-04-05
• Completion: 2024-04-05
• First posted: 2019-08-01
• Last updated: 2024-07-08

Locations

1 site across 1 country: Kenya