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Clinical Trials/ISRCTN18051843
ISRCTN18051843
Completed
Phase 3

First Line Antimicrobials in Children with Complicated Severe Acute Malnutrition

niversity of Oxford0 sites1,872 target enrollmentMay 9, 2017
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Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Not specified
Sponsor
niversity of Oxford
Enrollment
1872
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 9, 2017
End Date
July 31, 2020
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Age 2 months to 13 years inclusive
  • •2\. Severe malnutrition defined as:
  • •2\.1\. Kwashiorkor at any age
  • •2\.2\. For children between 6 to 59 months: MUAC \<11\.5cm or weight\-for length Z score \<\-3
  • •2\.3\. For children aged 2 to 5 months: MUAC \<11cm or weight\-for length Z score \<\-3
  • •2\.4\. For children aged 5 to 13 years: BMI\-for\-age Z score \<\-3 or MUAC \<11\.5cm
  • •3\. Admitted to hospital and eligible for intravenous antibiotics according to WHO guidelines
  • •4\. Planning to remain within the hospital catchment area and willing to come for specified visits during the 90 day follow up period
  • •5\. Informed consent provided by the parents/guardian

Exclusion Criteria

  • •1\. Known allergy or contraindication to penicillin, gentamicin, ceftriaxone or metronidazole
  • •2\. A specific and documented clinical indication for another class of antibiotic
  • •3\. Previously enrolled in this study

Outcomes

Primary Outcomes

Not specified

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