Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 14 of 14

List	Outcome	Time frame	Description
Primary	Mortality	90 days after enrolment.	Mortality is measured using source documents from medical records, verbal autopsy, or death or burial certificates in the community.
Secondary	Mortality during the first 7 days	7 days	Mortality during the first 7 days
Secondary	Mortality during the first 30 days	7 days	Mortality during the first 30 days
Secondary	Index admission inpatient mortality	Through index hospital admission, an average of 7 days.	Mortality during the index hospitalisation, measured using inpatient records.
Secondary	Mortality after discharge from index admission.	90 days after enrolment	Mortality occurring after discharge from the index hospital admission is measured using inpatient medical records, verbal autopsy, or death or burial certificates in the community.
Secondary	Grade 4 toxicity	Up to 7 days following enrolment	Grade 4 toxicity events are measured according to the Division of AIDS Tables for Grading the Severity of Adverse Events using medical records.
Secondary	Serious adverse events	90 days after enrolment.	Serious adverse events are measured using inpatient and outpatient medical records.
Secondary	Tolerability - relevant side effects during the first 7 day	7 days	Vomiting, diarrhoea, NG tube in place and convulsions during the first 7 days
Secondary	Causes of death.	90 days after enrolment	Causes of death, as determined by an endpoint review committee.
Secondary	Re-admission to hospital.	From discharge from hospital to 90 days after enrolment	Re-admission to hospital defined as at least one overnight stay in a hospital or health facility are measured using inpatient records.
Secondary	Duration of hospitalisation.	90 days after enrolment.	Total duration of hospitalisation is measured in days using inpatient records at the start and end of each admission to hospital.
Secondary	Duration of administration of antibiotics.	90 days after enrolment.	Duration of administration of intravenous antibiotics measured using inpatient records.
Secondary	Change in nutritional status	90 days after enrolment.	Change in nutritional status is measured using mid-upper arm circumference, weight-for-length, weight-for-age and length-for-age compared to at enrollment.
Secondary	Faecal carriage of bacteria expressing Extended Spectrum Lactamase (ESBL)	Through study completion an average of 90 days.	Faecal carriage of bacteria expressing Extended Spectrum Lactamase (ESBL) is measured using microbial culture and sensitivity testing of rectal swabs.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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