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Trial record 1 of 1 for:    NCT00513500
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Zambia Integrated Management of Malaria and Pneumonia Study (ZIMMAPS)

This study has been completed.
Sponsor:
Collaborators:
Center for International Health and Development
United States Agency for International Development (USAID)
Information provided by:
Boston University
ClinicalTrials.gov Identifier:
NCT00513500
First received: August 7, 2007
Last updated: July 13, 2010
Last verified: July 2010
History of Changes
Results First Received: April 27, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Health Services Research
Conditions: Pneumonia
Malaria
Interventions: Drug: Coartem and amoxicillin
Drug: Coartem

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Enhanced Treatment

Intervention: Treatment for malaria and pneumonia:

Treat malaria based on rapid diagnostic test with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days.

Treat pneumonia with half tablet (250mg amoxicillin) for children weighing 5 - 9.9kg and one tablet (250mg amoxicillin for children weighing 10-20kg three times a day for five days.
Current Practice

Control: Treatment for malaria and pneumonia referral Treat malaria based on fever with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days.

Refer children with pneumonia to the nearest health facility.

Participant Flow:   Overall Study
    Enhanced Treatment     Current Practice  
STARTED     1017     2108  
COMPLETED     976     2054  
NOT COMPLETED     41     54  
Lost to Follow-up                 35                 39  
Death                 2                 1  
Hospitalized                 4                 14  



  Baseline Characteristics
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Reporting Groups
  Description
Enhanced Treatment

Intervention: Treatment for malaria and pneumonia:

Treat malaria based on rapid diagnostic test with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days.

Treat pneumonia with half tablet (250mg amoxicillin) for children weighing 5 - 9.9kg and one tablet (250mg amoxicillin for children weighing 10-20kg three times a day for five days.
Current Practice

Control: Treatment for malaria and pneumonia referral Treat malaria based on fever with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days.

Refer children with pneumonia to the nearest health facility.
Total Total of all reporting groups

Baseline Measures
    Enhanced Treatment     Current Practice     Total  
Number of Participants  
[units: participants]
 		  1017     2108     3125  
Age  
[units: participants]
 		     
<=18 years     1017     2108     3125  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: months]
Mean ± Standard Deviation 		  22.6  ± 14.0     23.6  ± 14.7     23.3  ± 14.5  
Gender  
[units: participants]
 		     
Female     484     1028     1512  
Male     533     1080     1613  
Region of Enrollment  
[units: participants]
 		     
Zambia     1017     2108     3125  



  Outcome Measures
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1.  Primary:   Number of Children Who Received Early and Appropriate Treatment for Pneumonia.   [ Time Frame: one year ]
  Show Outcome Measure 1

2.  Primary:   Number of Children With Fever Who Received Coartem (Artemether-lumefantrine)   [ Time Frame: one year ]
  Show Outcome Measure 2

3.  Secondary:   Number of Children Who do Not Respond to Treatment for Pneumonia   [ Time Frame: one year ]
  Show Outcome Measure 3


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Imbalance in enrollment. More patients enrolled in the control arm possibly due to many control community health workers working full time and available to see patients all day.  


Results Point of Contact:  
Name/Title: Kojo Yeboah-Antwi
Organization: Boston University
phone: 617-414-1275
e-mail: kyantwi@bu.edu


No publications provided by Boston University

Publications automatically indexed to this study:


Responsible Party: Kojo Yeboah-Antwi, Center for International Health and Development
ClinicalTrials.gov Identifier: NCT00513500     History of Changes
Other Study ID Numbers: GHS-A-00-00020-00-5
Study First Received: August 7, 2007
Results First Received: April 27, 2010
Last Updated: July 13, 2010
Health Authority: United States: Institutional Review Board
Zambia: Research Ethics Committee