Ignite Creation Date:
2024-05-06 @ 12:48 AM
Last Modification Date:
2024-10-26 @ 10:55 AM
Study NCT ID:
NCT01669941
Status:
COMPLETED
Last Update Posted:
2017-03-06
First Post:
2012-08-15
Brief Title:
Efficacy of Intermittent Screening and Treatment or Intermittent Preventive Treatment IPT With Dihydroartemisinin-Piperaquine Versus IPT With Sulfadoxine-Pyrimethamine for the Control of Malaria in Pregnancy in Kenya
Sponsor:
Kenya Medical Research Institute
Organization:
Kenya Medical Research Institute
Study Overview
Official Title:
Intermittent Screening and Treatment IST or Intermittent Preventive Treatment IPT With Dihydroartemisinin-Piperaquine Versus IPT With Sulfadoxine-Pyrimethamine for the Control of Malaria in Pregnancy in Kenya a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2017-03
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:
STOP MiP KENYA
Brief Summary:
Malaria in pregnancy MiP due to Plasmodium falciparum infection is a major cause of maternal morbidity and poor birth outcomes Intermittent preventive treatment in pregnancy IPTp with Sulfadoxine pyrimethamine SP the administration of SP at predefined intervals in the second and third trimesters of pregnancy irrespective of the presence of malaria parasitemia is currently recommended for HIV-negative women in all areas with stable moderate to high transmission of malaria Due to increasing resistance to SP it is no longer used as a treatment for symptomatic malaria and the efficacy of IPTp-SP seems to be decreased This study aims to look at a new drug Dihydroartemisinin-Piperaquine DP for IPTp as well as to explore the strategy of intermittent screening and treatment in pregnancy ISTp with DP This strategy uses increased screening at time of focused antenatal care FANC with treatment of women who screen positive
The hypothesis is that the efficacy of both IPTp-DP and ISTp-DP will be associated with a reduction in malaria infection at delivery among HIV- women when compared to IPTp-SP in an area with decreasing malaria transmission and high levels of SP resistance in Kenya
The hypothesis is that the efficacy of both IPTp-DP and ISTp-DP will be associated with a reduction in malaria infection at delivery among HIV- women when compared to IPTp-SP in an area with decreasing malaria transmission and high levels of SP resistance in Kenya
Detailed Description:
Malaria in pregnancy MiP due to Plasmodium falciparum infection is a major cause of maternal morbidity and poor birth outcomes Pregnant women are at increased risk of more frequent and severe malaria infections than are non-pregnant women Intermittent preventive treatment in pregnancy IPTp the administration of treatment doses of an antimalarial at predefined intervals in the second and third trimesters of pregnancy irrespective of the presence of malaria parasitemia is currently recommended for HIV-negative women in all areas with stable moderate to high transmission of malaria The strategy is thought to work by providing intermittent clearance or suppression of parasites in the placenta and preventing new infections from occurring through the prophylactic effect of the recommended drug for IPTp sulfadoxine-pyrimethamine SP
SP is the only drug currently used for IPTp Due to increasing resistance to SP it is no longer used as a treatment for symptomatic malaria however IPTp with SP remains effective even in areas where SP resistance in children under five determined by in vivo efficacy studies is up to 26 SP therefore continues to be used for IPTp in many countries where it is no longer used for treatment of symptomatic malaria However more recent data from northern Tanzania and Malawi indicate that at higher rates of resistance IPTp-SP may no longer be effective and could potentially be harmful
In view of this data a search for alternatives to IPTp-SP is warranted One strategy would be to choose a different drug for IPTp Of the available combinations Dihydroartemisinin-Piperaquine DP remains one of the most attractive options because of the long half-life of piperaquine PQ and the demonstrated efficacy and safety in pregnancy Another strategy to consider is intermittent screening and treatment in pregnancy ISTp whereby there is increased screening at time of focused antenatal care FANC with treatment of women who screen positive The same properties long half-life tolerability safety once daily dosing which make DP a good choice for IPTp also make it one of the best available options for ISTp
This study aims to compare the efficacy of IPTp-SP against that of IPTp-DP and ISTp-DP to determine if these alternate strategies are associated with a reduction in malaria infection at delivery among HIV- women in an area with decreasing malaria transmission and high levels of SP resistance in Kenya
SP is the only drug currently used for IPTp Due to increasing resistance to SP it is no longer used as a treatment for symptomatic malaria however IPTp with SP remains effective even in areas where SP resistance in children under five determined by in vivo efficacy studies is up to 26 SP therefore continues to be used for IPTp in many countries where it is no longer used for treatment of symptomatic malaria However more recent data from northern Tanzania and Malawi indicate that at higher rates of resistance IPTp-SP may no longer be effective and could potentially be harmful
In view of this data a search for alternatives to IPTp-SP is warranted One strategy would be to choose a different drug for IPTp Of the available combinations Dihydroartemisinin-Piperaquine DP remains one of the most attractive options because of the long half-life of piperaquine PQ and the demonstrated efficacy and safety in pregnancy Another strategy to consider is intermittent screening and treatment in pregnancy ISTp whereby there is increased screening at time of focused antenatal care FANC with treatment of women who screen positive The same properties long half-life tolerability safety once daily dosing which make DP a good choice for IPTp also make it one of the best available options for ISTp
This study aims to compare the efficacy of IPTp-SP against that of IPTp-DP and ISTp-DP to determine if these alternate strategies are associated with a reduction in malaria infection at delivery among HIV- women in an area with decreasing malaria transmission and high levels of SP resistance in Kenya
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