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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
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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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Total Total of all reporting groups

Baseline Measures
   Enhanced Treatment   Current Practice   Total 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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

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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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.


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


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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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