Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00379821
Status:
COMPLETED
Last Update Posted:
2014-08-11
First Post:
2006-09-21
Brief Title:
Chloroquine Alone or in Combination for Malaria in Children in Malawi
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Longitudinal Study of Chloroquine as Monotherapy or in Combination With Artesunate Azithromycin or Atovaquone-Proguanil to Treat Malaria in Children in Blantyre Malawi
Status:
COMPLETED
Status Verified Date:
2014-07
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:
Malaria is a sickness caused by a germ that can get into a persons body when a mosquito bites them It can cause fever headache body aches and weakness It can even cause death especially in children When malaria is treated with the appropriate medicines it can be cured completely The purpose of this study is to find out if it is better to use chloroquine alone or in combination with another drug to most effectively treat malaria About 640 children with malaria aged 6 months to 5 years of age from the Blantyre Malaria Project Research Clinic at the Ndirande Health Center in Malawi will be in the study They will be treated with either chloroquine alone or a combination of chloroquine plus another medication azithromycin or artesunate or atovaquone-proguanil every time they get malaria for a year Blood samples will be collected and tested at least every 4 weeks Participants will be involved in the study for 1 year
Detailed Description:
Combination therapy is becoming the mainstay of malaria treatment In general the goal of combination therapy is to treat resistant infections successfully and to prevent the emergence and spread of resistance The antimalarial combination therapies currently in use were not designed based on optimal pairing of drugs to deter the development and spread of parasite resistance to the individual partner drugs in settings of high malaria transmission Careful studies are needed to identify the pharmacokinetic and pharmacodynamic properties of drug combinations that will deter resistance and prolong the useful therapeutic life of the next generation of antimalarial drug combinations Current in vivo methods for measuring antimalarial drug efficacy in high-transmission areas use a 14 or 28-day follow-up period but a single episode study misses several critical factors in assessing the efficacy and impact of antimalarial treatment When follow-up is extended beyond 28 days more cases of apparent resistance or treatment failure are found Single-episode studies cannot assess the impact of therapy on the incidence of malaria over time These limitations of standard in vivo studies have led the investigators to advocate longitudinal studies of drug efficacy In addition to measuring efficacy of individual treatments longitudinal studies measure sustained efficacy with repeated use of the same regimen over time a scenario that more accurately reflects the real-life use of anti-malarial medication The primary outcome of interest is the incidence of malaria episodes as well as the secondary outcomes of anemia and severe malaria are all highly relevant to public health policy-makers as they reflect not only the burden of disease but also the utilization of health resources Longitudinal studies also permit assessment of how pharmacokinetic properties of drugs affect the incidence of treatment episodes This is a randomized open-label longitudinal drug efficacy trial Participants will include 640 children aged 6 months to 5 years who are found to have uncomplicated malaria at the Blantyre Malaria Project Research Clinic at the Ndirande Health Centre in Blantyre Malawi After enrollment participants will be randomized to one of four treatment arms chloroquine alone or chloroquine in combination with artesunate atovaquone-proguanil AP or azithromycin The treatment outcome will be assessed through a standard 28-day efficacy study Participants will subsequently be evaluated every 4 weeks and encouraged to return to the study clinic any time they are ill during the course of one year If a new episode of uncomplicated malaria is diagnosed the participant will receive the same therapy as assigned on enrollment Polymerase chain reaction-corrected 28-day efficacy will be evaluated for each treatment episode The primary study objective is to compare annual incidence of malaria clinical episodes Secondary objectives are to assess anti-malarial drug efficacy at first administration by treatment arm assess anti-malarial drug efficacy during subsequent episodes of malaria by treatment arm measure prevalence of chloroquine resistant parasites during the trial by treatment arm assess effect of each treatment arm on anemia at the end of study participation assess safety of these drugs with repeated use determine the chloroquine blood levels at which chloroquine sensitive and resistant parasites are able to cause infection assess the effect of population movements on the risk of malaria infection and assess the spatial patterns and the environmental determinants of malaria infection Participants will be involved in study rela
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