A Study to Compare Different Antibiotics and Different Modes of Fluid Treatment for Children With Severe Pneumonia
SEARCH
Supportive Care and Antibiotics for Severe Pneumonia Among Hospitalized Children (SEARCH): A Pragmatic Randomised Controlled Trial
1 other identifier
interventional
4,392
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2019
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 29, 2019
CompletedFirst Posted
Study publicly available on registry
August 1, 2019
CompletedStudy Start
First participant enrolled
August 19, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 5, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 5, 2024
CompletedJuly 8, 2024
July 1, 2024
4.6 years
July 29, 2019
July 4, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mortality
Mortality of participants receiving any of the injectable antibiotic treatments who die within the first five days of admission measured from source documents, medical records, verbal autopsy or death certificates.
Up to Day 5
Secondary Outcomes (4)
Number of serious adverse events
Up to Day 30
Length of hospitalisation
Through duration of hospitalisation, an average of 5 days
Duration taken to tolerate full fluids by mouth
An average of 3 days
Mortality 30 days after enrollment
Day 30 post enrollment
Study Arms (6)
Benzyl penicillin/ampicillin + gentamicin & IV fluids
ACTIVE COMPARATORParticipants 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.
Ceftriaxone and IV fluids
EXPERIMENTALParticipants 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.
Amoxicillin-clavulanate and IV fluids
EXPERIMENTALParticipants 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.
Benzyl penicillin/ampicillin + gentamicin & NG feeds
EXPERIMENTALParticipants 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.
Ceftriaxone and NG feeds
EXPERIMENTALParticipants 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.
Amoxicillin-clavulanic acid and NG feeds
EXPERIMENTALParticipants 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.
Interventions
Benzyl penicillin is a penicillin antibiotic.
Gentamicin is an aminoglycoside antibiotic.
Ceftriaxone is a third generation cephalosporin antibiotic active against a wide range of gram negative and positive bacteria.
Amoxicillin Clavulanate is a combination of amoxicillin, a β-lactam antibiotic, and potassium clavulanate, a β-lactamase inhibitor.
Maintenance fluids administered for at least 24 hours.
Feeds given via nasogastric tube. Feeds may include cow's milk, breast milk, porridge, formula among others.
Ampicillin is a penicillin-type antibiotic.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Oxfordlead
- University of Nairobicollaborator
- London School of Hygiene and Tropical Medicinecollaborator
- National Institute for Health Research, United Kingdomcollaborator
- Department for International Development, United Kingdomcollaborator
- Medical Research Councilcollaborator
- Wellcome Trustcollaborator
- Kenya Ministry of Healthcollaborator
Study Sites (1)
Machakos Level 5 Hospital
Machakos, Kenya
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ambrose Agweyu, PhD
KEMRI-Wellcome Trust Research Programme, University of Oxford
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 29, 2019
First Posted
August 1, 2019
Study Start
August 19, 2019
Primary Completion
April 5, 2024
Study Completion
April 5, 2024
Last Updated
July 8, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share
Data requests will be considered by applying to the Data Governance Committee at the Kenya Medical Research Institute (KEMRI) Centre for Geographic Medicine Research-Kilifi, Kenya who will manage the process and ensure that appropriate ethical approval is in place and consent has been obtained for dissemination and use outside of the scope of the trial.