- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00142285
Zinc Pneumonia Outpatient Trial in Children < 2 Years
Efficacy of Zinc in the Treatment of Outpatient Pneumonia in an Urban Slum Among Children Less Than 2 Years Old
Study Overview
Detailed Description
This study is a follow up to an earlier study among hospitalised children less than two years old with severe pneumonia who were administered zinc as an adjuvant along with standard antimicrobial agents. That study found a 20% reduction in illness duration and hospitalisation, as well as a 3 - 9 fold reduction in treatment failure for children given zinc along with standard antimicrobial management. However, since most pneumonia is managed in an outpatient setting, it is important to know if it works in this setting as well. We hypothesise that zinc may act as an acute phase reactant in the early stages of outpatient non-severe pneumonia to reduce both the duration of illness and the likelihood of treatment failure.
To test this, we will randomise children less than two years old to receive either zinc or placebo can as an adjuvant to standard oral antimicrobial agents in the acute treatment of non-severe pneumonia in an outpatient urban setting. Oral antibiotics will be given for a standard five-day course, while zinc (20 mg) or placebo will be administered once-daily for 10 days. Patients will be followed up on a daily basis at home to monitor their progress and document compliance.
Outcomes will be a comparison between zinc and placebo groups on duration of illness, as measured by specific signs of pneumonia, and treatment failure, as measured by change of antibiotics or hospitalisation for failure to improve or worsening condition.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Dhaka, Bangladesh
- Kamalapur Urban Site, ICDDR,B: Centre for Health & Population Research
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Clinical diagnosis of pneumonia
Exclusion Criteria:
- Wheezing at presentation History of chronic lung, heart or other system disease suspected tuberculosis, active measles, severe malnutrition requiring hospitalisation, signs of systemic illness (sepsis, meningitis), those who have already received zinc/placebo supplements during this study, those known to be pre-treated with antibiotics prior to presenting to clinic
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Treatment failure
|
Duration of illness
|
Secondary Outcome Measures
Outcome Measure |
---|
Incidence of subsequent illness episodes (pneumonia and any other)
|
Collaborators and Investigators
Investigators
- Principal Investigator: W. Abdullah Brooks, MD, MPH, ICDDR,B: Centre for Health & Population Research
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2004-010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pneumonia
-
King Edward Memorial HospitalCompletedNosocomial Pneumonia | Healthcare-Associated Pneumonia | Aspiration Pneumonia | Ventilator-Associated PneumoniaIndia
-
Melinta Therapeutics, Inc.WithdrawnHospital-Acquired Bacterial Pneumonia | Ventilator-Associated Bacterial Pneumonia | Hospital-Acquired Pneumonia | Ventilator-Associated Pneumonia
-
Venatorx Pharmaceuticals, Inc.Biomedical Advanced Research and Development AuthorityNot yet recruitingHospital-acquired Pneumonia | Ventilator-associated Pneumonia
-
Hannover Medical SchoolCharite University, Berlin, Germany; University of LeipzigUnknownCOVID-19 | Bacterial Pneumonia | Viral Pneumonia | Pneumonia Due to Streptococcus Pneumoniae | Pneumonia Due to H. Influenzae | Pneumonia, Organism Unspecified | Pneumonia in Diseases Classified Elsewhere | Pneumonia Due to Other Specified Infectious OrganismsGermany
-
Nantes University HospitalSociété Française d'Anesthésie et de RéanimationCompletedPneumonia | Sepsis | Ventilator-Associated Pneumonia | Hospital Acquired PneumoniaFrance
-
PfizerCompletedVentilator-associated Pneumonia (VAP) | Nosocomial Pneumonia (NP)Bulgaria, France, Italy, Korea, Republic of, Mexico, Peru, Poland, Russian Federation, Spain, Turkey, United Kingdom, Vietnam, Philippines, China, Ukraine, Argentina, Brazil, Hungary, Romania, India, Japan, Taiwan, Latvia, Czechia, Slov... and more
-
Arpida AGTerminatedHospital-Acquired Pneumonia | Ventilator-Associated Pneumonia | Health-Care-Associated Pneumonia
-
University Medical Centre LjubljanaUniversity of Ljubljana, Faculty of MedicineUnknownCommunity Acquired Pneumonia | Ventilator Associated Pneumonia | Hospital Acquired PneumoniaSlovenia
-
ShionogiCompletedHospital Acquired Pneumonia (HAP) | Healthcare-associated Pneumonia (HCAP) | Ventilator Associated Pneumonia (VAP)Israel, Spain, United States, Belgium, Canada, Czechia, Estonia, France, Georgia, Germany, Hungary, Japan, Latvia, Philippines, Puerto Rico, Russian Federation, Serbia, Taiwan, Ukraine
-
Methodist Health SystemCompletedHospital-acquired Pneumonia | Ventilator-associated PneumoniaUnited States
Clinical Trials on Zinc sulphate (20 mg)
-
Bangabandhu Sheikh Mujib Medical University, Dhaka...CompletedAcne VulgarisBangladesh
-
International Centre for Diarrhoeal Disease Research...United States Agency for International Development (USAID)Completed
-
International Centre for Diarrhoeal Disease Research...Completed
-
Ayesha De CostaBoston Children's Hospital; Muhimbili University of Health and Allied Sciences and other collaboratorsCompleted
-
Centre For International HealthAll India Institute of Medical Sciences, New DelhiCompleted
-
Aga Khan UniversityNational Institute of Child Health, Karachi, Pakistan; Civil Hospital, Hyderabad...CompletedIncidence of Acute Diarrhea | Incidence of Abdominal PainPakistan
-
Ain Shams UniversityUnknown
-
UCSF Benioff Children's Hospital OaklandChildren's Hospital of Philadelphia; National Heart, Lung, and Blood Institute... and other collaboratorsCompleted
-
Centre For International HealthAll India Institute of Medical Sciences, New Delhi; Statens Serum Institut; Institut... and other collaboratorsCompleted
-
United States Army Research Institute of Environmental...Walter Reed Army Institute of Research (WRAIR)CompletedDiarrhea | MalariaUnited States, Kenya