Ciprofloxacin Versus Azithromycin for Children Hospitalised With Dysentery
Condition: Dysentery, Shigella; Shigellosis; Diarrhea
MeSH terms: Dysentery, Bacillary; Dysentery; Diarrhea
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the efficacy of 3 days of azithromycin (AZI) compared
      to 3 days of ciprofloxacin (CIP) (standard-of-care) for the treatment of children
      hospitalised with dysentery in Ho Chi Minh City.
    

Detailed description: 
      Antimicrobial resistance is a well-established international healthcare crisis and children
      with diarrhoeal infections represent a significant proportion of the global infectious
      disease burden. With the increasing rates of antimicrobial resistance observed in the
      organisms associated with children presenting with dysentery in Vietnam and the
      investigator's capacity to demonstrate international transmission events, new data regarding
      alternative treatment options such as azithromycin, in particular for the new
      highly-antimicrobial resistant S. sonnei, are urgently needed.

      The study team will perform a phase IV open label randomised controlled trial to compare the
      efficacy of AZI to CIP (standard-of-care) for the treatment of children hospitalised with
      dysentery in Ho Chi Minh City, Vietnam. Children aged 6 to 60 months presenting to the
      participating hospital with symptoms/signs of dysentery (diarrhoea with blood and/or mucus
      accompanied by 1 or more of: fever ≥37.8°C, abdominal pain and /or tenesmus) within the
      previous 72 hours will be enrolled to the study.

      After enrolment, participants will be managed according to WHO and local algorithms for
      children with bloody diarrhoea. In addition, after providing a stool sample, children will be
      randomly allocated to receive CIP 15mg/kg body weight/ twice daily or AZI 10mg/kg body
      weight/ daily for 3 days. After enrolment, children will be reviewed for clinical and
      microbiological response to treatment.
    

Intervention name(s): Ciprofloxacin; Azithromycin
Intervention type(s): Drug; Drug
Intervention description(s): Fluoroquinolone, ATC code: J01MA02
DNA-gyrase and topoisomerase IV inhibitor; Macrolide, ATC code: J01FA10
Binds to ribosomal 50S sub-unit inhibiting translocation of peptides thereby suppressing bacterial protein synthesis.
Intervention MeSH terms: Azithromycin; Ciprofloxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomization will be 1:1 to either AZI or CIP. Block randomization with stratification by hospital of enrolment, and variable block sizes of 4 and 6, respectively, will be used to assign subjects to treatment. The randomization list will be generated according to standard operating procedures without our organization. In brief, the Research Biostatistician (RB) will generate a randomization list using an in-house statistical code and transfer it to the central Study Pharmacist (SP). The SP will change the random seed to blind the RB and then run the code to prepare the final randomization list for treatment preparation. The randomization list will be saved and stored on a secure server.
After enrolment, children will be randomly allocated to one of two treatment arms: in one arm, children will be treated with the current standard of care, oral CIP 15mg/kg BW /twice daily for 3 days, while those in the other arm will receive oral AZI 10mg/kg BW/daily for 3 days.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Azithromycin; Ciprofloxacin; Children; Dysentery; Vietnam