Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00137566
Status:
UNKNOWN
Last Update Posted:
2010-07-07
First Post:
2005-08-28
Brief Title:
The Effect of Paracetamol in the Treatment of Non-severe Malaria in Children in Guinea-Bissau
Sponsor:
Bandim Health Project
Organization:
Bandim Health Project
Study Overview
Official Title:
The Effect of Paracetamol in the Treatment of Non-severe Malaria in Children in Guinea-Bissau
Status:
UNKNOWN
Status Verified Date:
2010-07
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The National Malaria Programme in Guinea-Bissau recommends paracetamol for all children treated for malaria We the investigators of the Bandim Health Project want to evaluate whether this treatment has any effect on
the well-being of the child
the parasite clearance time and
the rate of a re-appearance of parasites during 35 days of follow-up
Children presenting at Bandim Health Centre with malaria will be treated with chloroquine plus paracetamol or chloroquine plus placebo Blood samples will be obtained daily for the first 4 days and then once a week until day 35
the well-being of the child
the parasite clearance time and
the rate of a re-appearance of parasites during 35 days of follow-up
Children presenting at Bandim Health Centre with malaria will be treated with chloroquine plus paracetamol or chloroquine plus placebo Blood samples will be obtained daily for the first 4 days and then once a week until day 35
Detailed Description:
A Cochrane Review was unable to show a superior antipyretic effect of paracetamol compared with placebo in febrile children Recent research suggests that the time to parasite clearance in non-severe malaria is longer in children being given paracetamol As the costs associated with the use of paracetamol is not trivial and the risk of adverse effects is not negligible we want to evaluate the effects of paracetamol on
the well-being of the child
the parasite clearance time and
the recrudescence rate
Children presenting at Bandim Health Centre with symptoms of malaria and a malaria film showing mono-infection with Pfalciparum will following consent to participate randomly be allocated to treatment with chloroquine and paracetamol or with chloroquine and placebo
Blood samples will be obtained daily for the first 4 days The children will be visited and a malaria film taken on day 7 and then weekly until day 35 On inclusion and whenever parasitaemia is detected a capillary blood sample will be taken for PCR analyses to be able to distinguish re-infection from recrudescence
During follow-up children are recommended to present at the health centre in case of persistent fever or any other symptoms Examination and treatment will be free of charge Whenever a child has re-infection sulfadoxinepyrimethamine will be used for re-treatment following the recommendation of the National malaria Programme
After the inclusion of 80 children a preliminary analysis will be performed If 50 or more of the children in any of the study arms have reappearing parasitaemia the study will be terminated
If the parasite clearance time and especially the recrudescence rate is higher for children being given paracetamol the current recommendation from the National Malaria Programme should be reconsidered If children treated with paracetamol feel better during the acute illness making it more likely for them to have en adequate intake of food and liquid this benefit should be considered in the evaluation of the current recommendations
the well-being of the child
the parasite clearance time and
the recrudescence rate
Children presenting at Bandim Health Centre with symptoms of malaria and a malaria film showing mono-infection with Pfalciparum will following consent to participate randomly be allocated to treatment with chloroquine and paracetamol or with chloroquine and placebo
Blood samples will be obtained daily for the first 4 days The children will be visited and a malaria film taken on day 7 and then weekly until day 35 On inclusion and whenever parasitaemia is detected a capillary blood sample will be taken for PCR analyses to be able to distinguish re-infection from recrudescence
During follow-up children are recommended to present at the health centre in case of persistent fever or any other symptoms Examination and treatment will be free of charge Whenever a child has re-infection sulfadoxinepyrimethamine will be used for re-treatment following the recommendation of the National malaria Programme
After the inclusion of 80 children a preliminary analysis will be performed If 50 or more of the children in any of the study arms have reappearing parasitaemia the study will be terminated
If the parasite clearance time and especially the recrudescence rate is higher for children being given paracetamol the current recommendation from the National Malaria Programme should be reconsidered If children treated with paracetamol feel better during the acute illness making it more likely for them to have en adequate intake of food and liquid this benefit should be considered in the evaluation of the current recommendations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None