A Study to Compare Different Antibiotics and Different Modes of Fluid Treatment for Children With Severe Pneumonia
NCT ID: NCT04041791
Last Updated: 2024-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
4392 participants
INTERVENTIONAL
2019-08-19
2024-04-05
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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Benzyl penicillin/ampicillin + gentamicin & IV fluids
Participants are assigned to receive benzyl penicillin at 50,000 IU/kg every 6 hours or ampicillin 50mg/kg every 8 hours plus gentamicin 7.5 mg/kg once daily given intravenously (IV) or via intramuscular (IM) injection for a minimum of 48 hours and for up to 7 days.
Maintenance fluids will be given as a continuous infusion for at least 24 hours.
Intravenous fluid
Maintenance fluids administered for at least 24 hours.
Ampicillin
Ampicillin is a penicillin-type antibiotic.
Benzyl penicillin
Benzyl penicillin is a penicillin antibiotic.
Gentamicin Sulfate
Gentamicin is an aminoglycoside antibiotic.
Ceftriaxone and IV fluids
Participants are assigned to receive ceftriaxone at 50 mg/kg every 12 hours given IV or IM for a minimum of 48 hours and for up to 7 days.
Intravenous fluids will be given as a continuous infusion for at least 24 hours.
Ceftriaxone
Ceftriaxone is a third generation cephalosporin antibiotic active against a wide range of gram negative and positive bacteria.
Intravenous fluid
Maintenance fluids administered for at least 24 hours.
Amoxicillin-clavulanate and IV fluids
Participants are assigned to receive amoxicillin clavulanic acid at 30 mg/kg every 8 hours given IV or IM for a minimum of 48 hours and for up to 7 days.
Intravenous fluids will be given as a continuous infusion for at least 24 hours.
Amoxicillin Clavulanate
Amoxicillin Clavulanate is a combination of amoxicillin, a β-lactam antibiotic, and potassium clavulanate, a β-lactamase inhibitor.
Intravenous fluid
Maintenance fluids administered for at least 24 hours.
Benzyl penicillin/ampicillin + gentamicin & NG feeds
Participants are assigned to receive Benzyl penicillin at 50,000 IU/kg every 6 hours or ampicillin 50mg/kg every 8 hours plus gentamicin 7.5 mg/kg once daily given intravenously (IV) or via intramuscular (IM) injection for a minimum of 48 hours and for up to 7 days.
Nasogastric feeds will be given 3 hourly for at least 24 hours.
Nasogastric feeds
Feeds given via nasogastric tube. Feeds may include cow's milk, breast milk, porridge, formula among others.
Ampicillin
Ampicillin is a penicillin-type antibiotic.
Benzyl penicillin
Benzyl penicillin is a penicillin antibiotic.
Gentamicin Sulfate
Gentamicin is an aminoglycoside antibiotic.
Ceftriaxone and NG feeds
Participants are assigned to receive ceftriaxone at 50 mg/kg every 12 hours given IV or IM for up to 7 days.
Nasogastric feeds will be given 3 hourly for at least 24 hours.
Ceftriaxone
Ceftriaxone is a third generation cephalosporin antibiotic active against a wide range of gram negative and positive bacteria.
Nasogastric feeds
Feeds given via nasogastric tube. Feeds may include cow's milk, breast milk, porridge, formula among others.
Amoxicillin-clavulanic acid and NG feeds
Participants are assigned to receive amoxicillin clavulanic acid at 30 mg/kg every 8 hours given IV or IM for up to 7 days.
Nasogastric feeds will be given 3 hourly for at least 24 hours.
Amoxicillin Clavulanate
Amoxicillin Clavulanate is a combination of amoxicillin, a β-lactam antibiotic, and potassium clavulanate, a β-lactamase inhibitor.
Nasogastric feeds
Feeds given via nasogastric tube. Feeds may include cow's milk, breast milk, porridge, formula among others.
Interventions
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Ceftriaxone
Ceftriaxone is a third generation cephalosporin antibiotic active against a wide range of gram negative and positive bacteria.
Amoxicillin Clavulanate
Amoxicillin Clavulanate is a combination of amoxicillin, a β-lactam antibiotic, and potassium clavulanate, a β-lactamase inhibitor.
Intravenous fluid
Maintenance fluids administered for at least 24 hours.
Nasogastric feeds
Feeds given via nasogastric tube. Feeds may include cow's milk, breast milk, porridge, formula among others.
Ampicillin
Ampicillin is a penicillin-type antibiotic.
Benzyl penicillin
Benzyl penicillin is a penicillin antibiotic.
Gentamicin Sulfate
Gentamicin is an aminoglycoside antibiotic.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 for whom concurrent condition precludes the use of the first-line antibiotics for severe pneumonia such as readmission or meningitis
* 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
* For supportive care intervention (Intravenous fluids versus nasogastric feeds): shock or severe dehydration
* For supportive care intervention (Intravenous fluids versus nasogastric feeds): Child able to feed
* For supportive care intervention (Intravenous fluids versus nasogastric feeds): Vomiting everything
2 Months
59 Months
ALL
No
Sponsors
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University of Nairobi
OTHER
London School of Hygiene and Tropical Medicine
OTHER
National Institute for Health Research, United Kingdom
OTHER_GOV
Department for International Development, United Kingdom
OTHER_GOV
Medical Research Council
OTHER_GOV
Wellcome Trust
OTHER
Kenya Ministry of Health
OTHER_GOV
University of Oxford
OTHER
Responsible Party
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Ambrose Agweyu
Principal Investigator
Principal Investigators
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Ambrose Agweyu, PhD
Role: PRINCIPAL_INVESTIGATOR
KEMRI-Wellcome Trust Research Programme, University of Oxford
Locations
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Machakos Level 5 Hospital
Machakos, , Kenya
Countries
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Other Identifiers
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KEMRI/CGMR-C/141/3772
Identifier Type: -
Identifier Source: org_study_id
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