NCT02669654

Brief Summary

Background: At present pneumonia and malnutrition have become the leading causes of mortality among \<5-year-old children in developing countries. World Health Organization standard management of severe pneumonia and severe malnutrition requires hospitalization for supportive care. As many developing countries including Bangladesh do not have enough pediatric hospital beds to accommodate the demand for admission of all children with severe pneumonia and malnutrition, Investigators developed alternative treatment option such as "Day Care Approach", for those children who cannot be hospitalized, but are too sick to be managed in the community. After successful Day Care Approach of management of efficacy trials with severe childhood pneumonia and severe malnutrition, the next step is to conduct an effectiveness trial under "real life" condition, i.e. within the Health Systems of Bangladesh. Burden: Pneumonia is the leading cause of mortality in developing countries, being responsible for 1,368,000 (18%) of annual 7.6 million deaths, 95% occurring in developing countries. Similarly, malnutrition is a major health problem with an estimated 1.7 \& 3.6 million children dying annually because of Severe Acute Malnutrition \& Moderate Acute Malnutrition, respectively. Objectives: To assess \& implement the Day Care Approach of management of severe childhood pneumonia with or without Moderate Acute Malnutrition and/or severe underweight into existing Health Systems of Bangladesh as a safe \& cost effective alternative to Existing Treatment. Methods: A cluster randomized controlled trial will be conducted in Bangladesh by involving 16 clusters (Wards) in Dhaka \& 16 clusters (Unions) in rural areas that will be randomly assigned to intervention \& control arm. Children with severe pneumonia will be enrolled in (i) Tikatuli, (ii) Circular Road, (iii) Dhamrai Upazilla of Dhaka, (iv) Karimganj Upazillas to one of two management schemes: (i) Existing Treatment in control clusters or (ii) Day care Approach in intervention clusters by involving Comprehensive Reproductive Health Centres in urban and Health and Family Welfare Centres in rural areas. Outcome variables:

  • Primary: clinical treatment failure by day 6
  • Secondary: (i) Treatment failure between day 7-14 in children who are well on day 6 (ii) Cost effectiveness (iii) Referrals to hospitals (iv) Deaths

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,000

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2015

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 1, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 1, 2016

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
Last Updated

May 25, 2021

Status Verified

February 1, 2021

Enrollment Period

6 years

First QC Date

December 1, 2015

Last Update Submit

May 23, 2021

Conditions

Pneumonia Childhood

Outcome Measures

Primary Outcomes (1)

  • Clinical treatment failure by day 6 from severe pneumonia in the Day care clinics compare to the patients who will get treatment from Hospitals

    Patients will not recover within day 6 from severe pneumonia in the Day care clinics

    6 days

Secondary Outcomes (1)

  • Treatment failure between day 7-14 in children who are well on day 6 from severe pneumonia in the Day care clinics compare to the patients who will get treatment from Hospitals

    14 days

Study Arms (2)

Day-care management of Severe Pneumonia

EXPERIMENTAL

management in Day-care clinic

Other: Day-care management of Severe Pneumonia

Existing Treatment Centre (ETC)

NO INTERVENTION

Severe Pneumonia management in Existing Treatment Centre

Interventions

Day-care management of Severe PneumoniaOTHER

Day-care management of Severe Pneumonia

Day-care management of Severe Pneumonia

Eligibility Criteria

Age2 Months - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • to 59 months of age
  • Both male and female
  • Severe pneumonia with at least one of the following signs:
  • Central cyanosis
  • Hypoxaemia (Oxygen saturation \< 90% on pulse oximetry)
  • Severe respiratory distress
  • Grunting
  • Very severe chest indrawing
  • Signs of pneumonia with a general danger sign
  • Inability to breastfeed or drink
  • Lethargy
  • Reduced level of consciousness
  • Unconsciousness
  • Convulsions
  • Severe pneumonia with associated illnesses such as the following:
  • +5 more criteria

You may not qualify if:

  • Pneumonia
  • No pneumonia
  • Hospital-acquired/nosocomial pneumonia
  • Bronchiolitis
  • Severe Acute Malnutrition
  • Associated other severe diseases of childhood such as:
  • diarrhea with severe dehydration
  • Shock/severe sepsis
  • Meningitis/encephalitis
  • Bronchial asthma
  • Congenital Heart Disease
  • Participated in this study once and other study in the past 2 weeks
  • Received parenteral antibiotics for the current illness
  • Parents or legal guardians refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Icddr,B

Dhaka, 1212, Bangladesh

RECRUITING

Rural and Urban areas in Bangladesh

Dhaka, 1212, Bangladesh

RECRUITING

Related Publications (1)

  • Alam NH, Faruque AS, Ashraf H, Chisti MJ, Ahmed T, Sultana M, Khalequzzaman M, Ali S, Ahmed S, Nasrin S, Tariqujjaman M, Huq KATME, Amin R, Mollah AH, Kabir L, Shahidullah M, Khanam W, Islam K, Kim M, Vandenent M, Duke T, Gyr N, Fuchs GJ. Effectiveness, safety and economic viability of daycare versus usual hospital care management of severe pneumonia with or without malnutrition in children using the existing health system of Bangladesh: a cluster randomised controlled trial. EClinicalMedicine. 2023 Jun 6;60:102023. doi: 10.1016/j.eclinm.2023.102023. eCollection 2023 Jun.

    PMID: 37304498DERIVED

Study Officials

  • Nurul Hoque Alam, MD

    International Centre for Diarrhoeal Disease Research, Bangladesh

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nurul Hoque Alam, MD

CONTACT

9827001-10nhalam@icddrb.org

Md. Salam Khan

CONTACT

9886498salamk@icddrb.org

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2015

First Posted

February 1, 2016

Study Start

November 1, 2015

Primary Completion

October 31, 2021

Study Completion

October 31, 2021

Last Updated

May 25, 2021

Record last verified: 2021-02

Locations

BA(2)