Zinc as Adjunct to Treatment of Pneumonia (EcuaPAZ)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Corporacion Ecuatoriana de Biotecnologia.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Boston University
Information provided by:
Corporacion Ecuatoriana de Biotecnologia
ClinicalTrials.gov Identifier:
NCT00513929
First received: August 7, 2007
Last updated: January 27, 2009
Last verified: January 2009
  Purpose

The propose of this study is to evaluate if zinc given as an adjunct to standard treatment of severe pneumonia in young children shortens the duration and reduces treatment failure, and if these effects are pathogen-dependant.


Condition Intervention
Pneumonia
Dietary Supplement: Zinc sulphate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Zinc as an Adjunct to Treatment of Pneumonia in Young Children

Resource links provided by NLM:


Further study details as provided by Corporacion Ecuatoriana de Biotecnologia:

Primary Outcome Measures:
  • Time (hours) to resolution of clinical signs of pneumonia [ Time Frame: 31 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time (hours) to resolution of clinical signs of pneumonia by type of associated pathiogens ( bacterial/viral) [ Time Frame: 31 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 450
Study Start Date: August 2007
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: X: Zinc sulphate Dietary Supplement: Zinc sulphate
Arm X : Zinc sulphate 10 mg will be given orally twice a day since admission to resolution of pneumonia episode in addition to standard antibiotic treatment.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   2 Months to 59 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children from 2 to 59 months of age with severe pneumonia admitted to the Children´s Hospital, whose parents are willing to provide written informed consent will be eligible for participation

Exclusion Criteria:

  • Children suffering from marasmus or kwashiorkor, measles, pneumonia due to aspiration of a foreign body, hepatic or renal disease, sepsis, congenital abnormalities (cardiac, renal, or genetic), complicated pneumonia (lung abscess, pleural effusion, pneumatocele, atelectasis), or severe anemia (hemoglobin less than 8 g/dL [this cut-off is based on clinical experience with severe anemia at high altitude])
  • Children whose parents refuse to provide written informed consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00513929

Contacts
Contact: Fernando E Sempertegui, MD 593 2 2520638 fersempert@andinanet.net

Locations
Ecuador
Baca Ortiz Children´s Hospitals Recruiting
Quito, Ecuador
Principal Investigator: Fernando Sempértegui, MD         
Sponsors and Collaborators
Corporacion Ecuatoriana de Biotecnologia
Boston University
Investigators
Principal Investigator: Fernando E Sempertegui, MD Corporacion Ecuatoriana de Biotecnologia
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fernando Sempértegui, MD, Corporación Ecuatoriana de Biotecnología
ClinicalTrials.gov Identifier: NCT00513929     History of Changes
Other Study ID Numbers: TH-ZN-01-EC
Study First Received: August 7, 2007
Last Updated: January 27, 2009
Health Authority: Ecuador: Ethical Committee

Keywords provided by Corporacion Ecuatoriana de Biotecnologia:
Severe Pneumonia
Zinc
Associated pathogens
Severe Pneumonia by type of associated pathogens
Severe Pneumonia by basal plasma zinc status

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Zinc
Zinc Sulfate
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Astringents
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014