Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00167843
Status:
COMPLETED
Last Update Posted:
2013-01-24
First Post:
2005-09-11
Brief Title:
Reducing the Effects of Malaria in Children by Administering Repeated Preventive Doses
Sponsor:
Albert Schweitzer Hospital
Organization:
Albert Schweitzer Hospital
Study Overview
Official Title:
A Longitudinal Study Assessing the Infectious Status and Immunity of Mothers and Their Children in Lambaréné Including Intermittent Treatment of Children With Sulfadoxine-pyrimethamine for Malaria Control and Its Impact on Long-term Health
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
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 general goal of the project is to assess the infectious status and immunity of mothers and children living in a malaria region A major part of the study involves administering an effective antimalarial sulfadoxine-pyrimethamine Fansidar to children at the same timepoints as vaccinations ie at age 3 9 and 15 months The main objective is to study safety efficacy and consequences of such a strategy in particular the ability to reduce the risk of anemia
Detailed Description:
More than 15 million deaths of African children under 5 years of age are due to Plasmodium falciparum malaria There is an urgent need for available and affordable strategies to control malaria morbidity in childhood
Malaria control measures have been assessed for their potential to reduce intensity of infection in order to decrease the risk of malaria It has been shown that malaria prevention using drugs is potentially capable to reduce malaria morbidity school absenteeism and all-cause mortality However prevention using drugs in the first years of life can also result in the loss or delay of acquired resistance which can lead to a rebound phenomenon ie an increased risk of severe malaria after the therapy ended In a recent study on intermittent treatment with Fansidar at 2 3 and 9 months of age the number of malaria cases during the first 12 months of life was significantly reduced and no rebound effect was observed This study has demonstrated that the intermittent administration of Fansidar is safe and has beneficial effects for the children However the effectiveness decreased some months after discontinuing the drug The promising effect of the intermittent administration of fansidar shown in this study needs to be confirmed in areas of different endemicity such as Lambaréné Gabon It is assumed that a more extended intermittent application of Fansidar than performed in the above example would likely result in a longer period of protection from malaria and the extended intermittent administration of Fansidar should not lead to rebound effects resulting in a higher occurrence of malaria
The framework of this study offers a unique opportunity to study characteristics of infectious disease of importance in the Lambaréné area and the development of resistance against microbes at the maternofetal motherfoetus interface Comparable studies will simultaneously take place in two associated study sites Kumasi and Tamale with different malaria endemicity in Ghana West Africa
Comparison Comparison of malaria attacks in children with and without intermittent Fansidar treatment with drug administration at months 3 and 9 alongside with routine vaccinations delivered through child vaccination programme and an additional administration at month 15
Malaria control measures have been assessed for their potential to reduce intensity of infection in order to decrease the risk of malaria It has been shown that malaria prevention using drugs is potentially capable to reduce malaria morbidity school absenteeism and all-cause mortality However prevention using drugs in the first years of life can also result in the loss or delay of acquired resistance which can lead to a rebound phenomenon ie an increased risk of severe malaria after the therapy ended In a recent study on intermittent treatment with Fansidar at 2 3 and 9 months of age the number of malaria cases during the first 12 months of life was significantly reduced and no rebound effect was observed This study has demonstrated that the intermittent administration of Fansidar is safe and has beneficial effects for the children However the effectiveness decreased some months after discontinuing the drug The promising effect of the intermittent administration of fansidar shown in this study needs to be confirmed in areas of different endemicity such as Lambaréné Gabon It is assumed that a more extended intermittent application of Fansidar than performed in the above example would likely result in a longer period of protection from malaria and the extended intermittent administration of Fansidar should not lead to rebound effects resulting in a higher occurrence of malaria
The framework of this study offers a unique opportunity to study characteristics of infectious disease of importance in the Lambaréné area and the development of resistance against microbes at the maternofetal motherfoetus interface Comparable studies will simultaneously take place in two associated study sites Kumasi and Tamale with different malaria endemicity in Ghana West Africa
Comparison Comparison of malaria attacks in children with and without intermittent Fansidar treatment with drug administration at months 3 and 9 alongside with routine vaccinations delivered through child vaccination programme and an additional administration at month 15
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