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Efficacy of ArTiMist™ in Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01047436
First Posted: January 12, 2010
Last Update Posted: January 27, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Xidea Solutions Limited
Information provided by:
Proto Pharma Ltd
Results First Submitted: September 29, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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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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
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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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 ]

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 ]

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 ]

4.  Secondary:   Parasite Clearance Time   [ Time Frame: 3h (hours), 6h, 12h, 18h, 24h, 30h, 36h, 48h, 54h, 60h ]

5.  Secondary:   Parasite Reduction Ratio (PRR) at 24 h (Hours) After the First Dose   [ Time Frame: 24 hours after first dose ]

6.  Secondary:   Parasite Reduction Ratio (PRR) at 12 Hours After the First Dose   [ Time Frame: 12 h (hours) after first dose ]


  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
No text entered.


  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.


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


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

Responsible Party: Mr Clive Booles Director of Development, ProtoPharma
ClinicalTrials.gov Identifier: NCT01047436     History of Changes
Other Study ID Numbers: ART003
First Submitted: January 8, 2010
First Posted: January 12, 2010
Results First Submitted: September 29, 2010
Results First Posted: January 14, 2011
Last Update Posted: January 27, 2011