Trial in Childhood Pneumonia With Malnutrition
Recruitment status was Recruiting
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Purpose
The impetus for this study came from the findings of the investigators' recently published study entitled "Day-care management of severe and very severe pneumonia, without associated co-morbidities such as severe malnutrition, in an urban health clinic in Dhaka, Bangladesh". If day-care management is found to have comparable efficacy to that of hospital management of severe and very severe pneumonia in children then they could be managed at outpatient, day-care set ups reducing hospitalization and thus freeing beds for management of other children who need hospital care. Such management could also be implemented in rural areas of Bangladesh and potentially to other developing countries. Additionally, availability of the treatment facility in community set-ups will be cost and time saving for the population. But, as patients with severe malnutrition were excluded from the pilot study for ethical reasons, the peer reviewers of the manuscript felt that the study findings cannot be applied to the treatment of severe and very severe pneumonia in general. Similarly, management of severely malnourished children with associated complications relies on hospital-based treatment. In another study, a day-care clinic approach by providing antibiotics, micronutrients, diet and supportive care to severely malnourished children showed that they could be successfully managed at existing day-care clinics using a protocolized approach. Therefore, after the successful conduction and publication of these two study results in international journals with severe and very severe pneumonia as well as severe malnutrition at the day-care clinic, it is mandatory to perform the final study where the investigators will include severe malnutrition as well as associated co-morbidities to be applied to the treatment of severe and severe pneumonia in children in general to make the treatment approach more widely applicable.
| Condition | Intervention | Phase |
|---|---|---|
|
Malnutrition Pneumonia |
Other: Day-care clinic Other: Hospital Management |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized, Controlled Clinical Trial of Day-care Based and Hospitalized Management of Severe and Very Severe Pneumonia, With Severe Malnutrition, With/Without Associated Co-morbidities in Children |
- Proportion of success with 95% confidence interval (CI) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- Case fatality rate with 95% CI -day-care clinic/hospital [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- Proportion of failure rate with 95% CI [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- Duration of illness (d) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- Proportion of referral & discontinuation with 95% CI [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- Duration of success (d) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- Development of complications [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- Cost of treatment [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 440 |
| Study Start Date: | November 2008 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Day-care clinic
Inj. Ceftriaxone and other micronutrients will be given to children at the day-care clinic from 8:00 a.m. to 5:00 p.m. daily.
|
Other: Day-care clinic
Inj. Ceftriaxone and other micronutrients will be given to children at the day-care clinic from 8:00 a.m. to 5:00 p.m. daily.
|
|
Hospital management
Hospital management: all children admitted at the hospital will be managed with injection Ceftriaxone and other micronutrients for the total duration of hospitalization as per approved protocol.
|
Other: Hospital Management
Inj. Ceftriaxone and other micronutrients will be given to children at the hospital from admission till discharge.
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 2 Months to 59 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age: 2 to 59 months
- Sex: Both boys and girls
- Severe and very severe pneumonia
- Severe malnutrition (defined as < - 3 weight-for-height Z-score)
- Attending Radda Clinic or ICHSH between 8:00 to 16:00
- Written informed consent by respective parents/guardians
Exclusion Criteria:
- Non-severe pneumonia
- Nosocomial pneumonia
- Bronchiolitis
- Bronchial asthma
- Living long distance (>5 km) from the Radda Clinic and ICHSH
- Visits during late hours of the day (after 16:00)
- Parents/guardians not consenting for enrolment of children in the study
Contacts and Locations| Contact: Hasan Ashraf, MD | 008802-8860523-32 ext 2355 | ashrafh@icddrb.org |
| Bangladesh | |
| International Centre for Diarrhoeal Disease Research Bangladesh | Recruiting |
| Dhaka, Bangladesh, 1212 | |
| Contact: Hasan Ashraf, MD 008802-8860523-32 ext 2355 ashrafh@icddrb.org | |
| Principal Investigator: Hasan Ashraf, MD | |
More Information
No publications provided
| Responsible Party: | International Centre for Diarrhoeal Disease Research, Bangladesh |
| ClinicalTrials.gov Identifier: | NCT00968370 History of Changes |
| Other Study ID Numbers: | 2008-009 |
| Study First Received: | August 28, 2009 |
| Last Updated: | June 5, 2013 |
| Health Authority: | Bangladesh: Ethical Review Committee |
Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
|
Severe and very severe pneumonia severe malnutrition children day-care management hospital management |
Additional relevant MeSH terms:
|
Pneumonia Malnutrition Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Nutrition Disorders |
Micronutrients Trace Elements Growth Substances Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013