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Zinc as Adjunct to Treatment of Pneumonia (EcuaPAZ)

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ClinicalTrials.gov Identifier: NCT00513929
Recruitment Status : Unknown
Verified January 2009 by Corporacion Ecuatoriana de Biotecnologia.
Recruitment status was:  Recruiting
First Posted : August 9, 2007
Last Update Posted : January 29, 2009
Sponsor:
Collaborator:
Boston University
Information provided by:
Corporacion Ecuatoriana de Biotecnologia

Brief Summary:
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 or disease Intervention/treatment Phase
Pneumonia Dietary Supplement: Zinc sulphate Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Zinc as an Adjunct to Treatment of Pneumonia in Young Children
Study Start Date : August 2007
Estimated Primary Completion Date : May 2010
Estimated Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Time (hours) to resolution of clinical signs of pneumonia [ Time Frame: 31 months ]

Secondary Outcome Measures :
  1. Time (hours) to resolution of clinical signs of pneumonia by type of associated pathiogens ( bacterial/viral) [ Time Frame: 31 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
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
First Posted: August 9, 2007    Key Record Dates
Last Update Posted: January 29, 2009
Last Verified: January 2009

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
Astringents
Dermatologic Agents