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Efficacy of ArTiMist™ in Children

This study has been completed.
Sponsor:
Collaborator:
Xidea Solutions Limited
Information provided by:
Proto Pharma Ltd
ClinicalTrials.gov Identifier:
NCT01047436
First received: January 8, 2010
Last updated: January 26, 2011
Last verified: January 2011
History of Changes
Results First Received: September 29, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Falciparum Malaria
Interventions: Drug: Quinine
Drug: Artemether

  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
Patients were recruited at a single study centre in Rwanda during December 2009.

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
ArTiMist Artemether Sublingual Spray 3 mg/kg administered at 0, 8, 24, 36, 48, and 60 hours
Intravenous Quinine Intravenous Quinine. Loading dose of 20 mg/kg and subsequent doses of 10 mg/kg 8 hourly

Participant Flow:   Overall Study
    ArTiMist     Intravenous Quinine  
STARTED     16     15  
COMPLETED     15     15  
NOT COMPLETED     1     0  
Protocol Violation                 1                 0  



  Baseline Characteristics
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Reporting Groups
  Description
ArTiMist Artemether Sublingual Spray 3 mg/kg administered at 0, 8, 24, 36, 48, and 60 hours
Intravenous Quinine Intravenous Quinine. Loading dose of 20 mg/kg and subsequent doses of 10 mg/kg 8 hourly
Total Total of all reporting groups

Baseline Measures
    ArTiMist     Intravenous Quinine     Total  
Number of Participants  
[units: participants]
 		  16     15     31  
Age  
[units: participants]
 		     
<=18 years     16     15     31  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  3.03  ± 1.50     3.64  ± 2.46     3.32  ± 2.00  
Gender  
[units: participants]
 		     
Female     9     7     16  
Male     7     8     15  
Region of Enrollment  
[units: participants]
 		     
Rwanda     16     15     31  



  Outcome Measures
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1.  Primary:   Parasitological Success Defined as a Reduction in Parasite Count of ≥ 90% of Baseline at 24 Hours After the First Dose   [ Time Frame: 24 hours after first dose ]
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2.  Primary:   Time for Parasite Count to Fall by 90% PCT(90)   [ Time Frame: 3h (hours), 6h, 12h, 18h, 24h, 30h, 36h, 48h, 54h, 60h ]
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3.  Primary:   Time for Parasite Count to Fall by 50% PCT(50)   [ Time Frame: 3 h (hours) , 6h, 12h, 18h, 24h, 30h, 36h, 48h, 54h, 60h ]
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4.  Secondary:   Parasite Clearance Time   [ Time Frame: 3h (hours), 6h, 12h, 18h, 24h, 30h, 36h, 48h, 54h, 60h ]
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5.  Secondary:   Parasite Reduction Ratio (PRR) at 24 h (Hours) After the First Dose   [ Time Frame: 24 hours after first dose ]
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6.  Secondary:   Parasite Reduction Ratio (PRR) at 12 Hours After the First Dose   [ Time Frame: 12 h (hours) after first dose ]
  Show Outcome Measure 6


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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
No text entered.  


Results Point of Contact:  
Name/Title: Dr D Bendel
Organization: Xidea Solutions Limited
e-mail: daryl@xideasolutions.com


No publications provided


Responsible Party: Mr Clive Booles Director of Development, ProtoPharma
ClinicalTrials.gov Identifier: NCT01047436     History of Changes
Other Study ID Numbers: ART003
Study First Received: January 8, 2010
Results First Received: September 29, 2010
Last Updated: January 26, 2011
Health Authority: Rwanda: Ethics Committee