- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00327964
Rapid Diagnostic Tests (RDTs) for Malaria in Kampala, Uganda
25. februar 2020 opdateret af: University of California, San Francisco
Utility of Rapid Diagnostic Tests (RDTs) for Malaria in Kampala, Uganda
Malaria remains a disease that causes much death and sickness, especially in sub-Saharan Africa.
An accurate, simple, and inexpensive method of diagnosing malaria is urgently needed.
The purpose of this study is to evaluate a different diagnostic method compared to those most frequently used.
The study may also identify the factors causing false positive and false negative results using the alternative method.
Participants will be 600 Ugandan children aged 1-10 years who are enrolled in protocol 04-068.
Those who develop a fever over the 12 month duration of the study will be tested for malaria by both the standard and the new methods.
These tests will require a few drops of blood to be collected by finger prick.
Subjects will be treated on the basis of standard diagnostic testing (i.e.
expert microscopy).
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
Malaria remains one of the most devastating infectious diseases, causing high morbidity and mortality especially in sub-Saharan Africa.
The need for an accurate, simple, and inexpensive method to diagnose malaria has become increasingly urgent.
Rapid diagnostic tests (RDTs), based on detection of Plasmodium antigens, may represent a more practical diagnostic tool than traditional light microscopy.
This longitudinal study's objectives are (1) to evaluate the clinical performance (sensitivity, specificity, positive and negative predictive values) of RDTs, as compared with presumptive diagnosis and microscopy, for the diagnosis of malaria in children in Kampala, Uganda, and (2) to identify host and test factors that lead to false positive and false negative RDT results by comparison with polymerase chain reaction (PCR) analysis.
Study subjects in this RDT study will have already been enrolled in a larger on-going longitudinal study of antimalarial drug efficacy, tolerability, and safety that began at the Kampala study site in late 2004.
In the RDT study, over a one-year period, study participants' blood samples will be evaluated with the current gold standard for malaria diagnosis (microscopy) as well as two types of RDT whenever they present with a new fever episode (the first fever after study enrollment, or a fever that occurs more than 14 days after the patient's most recently diagnosed episode of malaria).
As part of the on-going longitudinal drug efficacy trial, probability sampling was used to select a random sample of 600 children, who will be followed for three years for all their health-care needs.
The RDT study will involve evaluation of the cohort over 12 months, beginning in approximately the third quarter of 2005.
This protocol is a substudy of 04-068.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
600
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Kampala, Uganda
- Mulago Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
1 år til 11 år (Barn)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
601 children enrolled in a longitudinal antimalarial treatment efficacy trial in Kampala, Uganda.
Beskrivelse
Inclusion Criteria: Member of the cohort participating in clinical trial of antimalarial drug efficacy in Kampala, which was enrolled based on criteria including the following characteristics:
- Ages 1-10 (at time of original enrollment)
- Parents' or guardians' agreement to bring the child to the study clinic for any fevers or other illnesses
- Agreement to avoid medications administered outside the study
- Intention to remain in Kampala for the full study period
- Native Ugandan
Exclusion Criteria:
- Presence of any known serious chronic disease (e.g. AIDS, sickle cell disease, malignancy)
- Serious side effects to study medications used in cohort clinical trial of antimalarial drug efficacy
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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study population
601 children enrolled in an on-going longitudinal antimalarial treatment efficacy trial in Kampala, Uganda.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
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RDT accuracy
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Heidi Hopkins, MD, University of California, San Francisco
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. oktober 2005
Primær færdiggørelse (Faktiske)
1. maj 2006
Studieafslutning (Faktiske)
1. maj 2006
Datoer for studieregistrering
Først indsendt
18. maj 2006
Først indsendt, der opfyldte QC-kriterier
18. maj 2006
Først opslået (Skøn)
19. maj 2006
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
28. februar 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. februar 2020
Sidst verificeret
1. februar 2020
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NIH/DMID 05-0110
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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