Ciprofloxacin Versus Azithromycin for Children Hospitalised With Dysentery

NCT ID: NCT03854929

Last Updated: 2023-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 364 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-11
• Study Completion Date: 2022-07-12

Brief 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.

Conditions

Dysentery, Shigella; Shigellosis; Diarrhea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ciprofloxacin

Each sachet CIPROFLOXACIN of 3g powder contains: 250mg Ciprofloxacin HCl, dissolved in water, dosed to 15mg/kg body weight /twice daily (apart 12 hours)/ 3 days.

Group Type: ACTIVE_COMPARATOR

Ciprofloxacin

Intervention Type: DRUG

Fluoroquinolone, ATC code: J01MA02

DNA-gyrase and topoisomerase IV inhibitor

Azithromycin

Each sachet AZICINE of 1.5 g powder contains: 250mg of Azithromycin dihydrate, dissolved in warm water, dosed to 10mg/kg body weight /daily/ 3 days

Group Type: EXPERIMENTAL

Azithromycin

Intervention Type: DRUG

Macrolide, ATC code: J01FA10

Binds to ribosomal 50S sub-unit inhibiting translocation of peptides thereby suppressing bacterial protein synthesis.

Interventions

Ciprofloxacin

Fluoroquinolone, ATC code: J01MA02

DNA-gyrase and topoisomerase IV inhibitor

Intervention Type: DRUG

Azithromycin

Macrolide, ATC code: J01FA10

Binds to ribosomal 50S sub-unit inhibiting translocation of peptides thereby suppressing bacterial protein synthesis.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male or female aged 6 months to 60 months at time of hospital presentation.

2. Have symptoms and/or signs of dysentery, specifically passing stools containing mucus and/or blood with/without abdominal pain, tenesmus or fever (≥37.8˚C).

3. Be eligible for treatment with oral medication in the opinion of the admitting physician (i.e. no clinical requirement for parenteral treatment on admission).

4. Be within 72 hours of the onset of signs/symptoms.

5. Have a parent/guardian present at admission who can provide written informed consent.

Exclusion Criteria

1. Those known to have specific medical (patients with known prolongation of the QT interval, congenital long QT syndrome)/surgical conditions which may affect disease severity/presentation or response to treatment (e.g. affecting antimicrobial absorption), including:

1. gastrointestinal abnormalities, including short bowel syndrome, chronic (inflammatory or irritable) bowel disease.

2. inherited or acquired immune system deficiency rendering the patient immunocompromised, including chronic/long-term steroid treatment or other immunosuppressive treatment

2. Presentation with severe infection requiring parenteral antimicrobial treatment, including shock jaundice, extensive gastrointestinal bleeding, convulsion , drowsiness or coma, reduced or less movement when stimulated, tachypnea > 60 times per minute, grunting, chest retraction, refuse to suck.

3. Known hypersensitivity to any of the trial drugs (CIP or AZI).

4. Coexisting infection requiring other or additional antimicrobials to be prescribed/ administered.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 60 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Number 2 Children's Hospital, Ho Chi Minh City

OTHER

Sponsor Role: collaborator

University of Liverpool

OTHER

Sponsor Role: collaborator

Oxford University Clinical Research Unit, Vietnam

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen Stephen, Professor

Role: PRINCIPAL_INVESTIGATOR

Oxford University Clinical Research Unit

Locations

Children's Hospital 2

Ho Chi Minh City, , Vietnam

Countries

Vietnam

Other Identifiers

26EN

Identifier Type: -

Identifier Source: org_study_id