Antibiotics for Children with Severe Diarrhoea (ABCD) Trial

Center For Public Health Kinetics0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Children aged 2 â?? 23 months, presenting to a designated health care facility at a participating study site WITH
•2.Diarrhoea per caregiver perception AND at least 3 unusually loose or watery stools in the previous 24 hours,
•3.Diarrhoea for less than 14 days prior to screening AND with at least one of the following criteria at presentation:
•3.1.Signs of some or severe dehydration as per WHO pocket Book 2013
•3.2.Moderately wasted as defined by a mid-upper arm circumference (MUAC) less than 125 mm (but greater than or equal to 115 mm) or a weight-for-length z score (WLZ) greater than -3SD and less than or equal to -2SD after rehydration during stabilization period or
•3.3.Severely stunted (Length-for-age z-score (LAZ) <-3 SD) AND
•4.Parent or guardian (caregiver) willing to allow household visits on DAY 2 and DAY 3 and willing to return to facility on DAY 90 AND
•5.Parent or guardian (caregiver) provides a consent for trial participation on behalf of the child

•1.Dysentery (gross blood in stool reported by parent or observed by HCW)
•2.Suspected Vibrio Cholerae infection (determined according to WHO guidelines or clinical suspicion)
•3.Previously or currently enrolled in the ABCD study
•4.Concurrently enrolled in another interventional clinical trial
•5.Sibling or other child in the household enrolled in the ABCD study and currently taking study medication
•6.Signs of associated infections (pneumonia, severe febrile illness, meningitis, mastoiditis or acute ear infection)requiring alternate antibiotic treatment
•7.Documented antibiotic use in the 14 days prior to screening (not including standard use of prophylactic antibiotics, i.e. co-trimoxazole use in HIV-exposed children)
•8.Documented use of metronidazole within the last 14 days
•9.Known allergy or contraindication to azithromycin antibiotics
•10.Severe acute malnutrition(SAM)defined as weight-for-length z-score less than â??3 SD, or MUAC less than 115 mm or edema of both feet,OR
•11.Living too far from the enrolment health center to ensure adequate Directly Observed Therapy(DOT)on DAY 2 and DAY 3.

发起方

Center For Public Health Kinetics