Pneumonia Clinical Trial
— SEARCHOfficial title:
Supportive Care and Antibiotics for Severe Pneumonia Among Hospitalized Children (SEARCH): A Pragmatic Randomised Controlled Trial
Verified date | May 2024 |
Source | University of Oxford |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 4392 |
Est. completion date | April 5, 2024 |
Est. primary completion date | April 5, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Months to 59 Months |
Eligibility | 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 - 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 due to dehydration 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 |
Country | Name | City | State |
---|---|---|---|
Kenya | Machakos Level 5 Hospital | Machakos |
Lead Sponsor | Collaborator |
---|---|
University of Oxford | 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 |
Kenya,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Number of serious adverse events | Serious adverse events that my be likely or definitely related to any of the interventions given to the participants. Serious adverse events include death, a life threatening event, persistent or significant disability or incapacity, hospitalisation or prolonged hospitalisation. | Up to Day 30 | |
Secondary | Length of hospitalisation | Total days a participant is admitted or receives inpatient care measured in days using hospital records at the start and end of each admission. | Through duration of hospitalisation, an average of 5 days | |
Secondary | Duration taken to tolerate full fluids by mouth | Number of days it takes for participants to fully tolerate fluids orally. | An average of 3 days | |
Secondary | Mortality 30 days after enrollment | Number of participants who die within 30 days of enrollment into the study measured using source documents, medical records, verbal autopsy or death certificates. | Day 30 post enrollment |
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