- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01736319
Artemisinin-resistant Malaria in Cambodia
Artemisinin-resistant Plasmodium Falciparum Malaria in Cambodia
Background:
- Artemisinin-based combination therapies (ACTs) are the first-line treatments for malaria. ACTs are highly effective, but malaria caused by the Plasmodium falciparum parasite is becoming resistant to some ACTs. ACT-resistant malaria has shown up in some parts of Cambodia, but not yet in other parts of the country. This has been shown by treating patients with ACTs, checking the amount of parasites in the patient s blood every 6 hours, and calculating the rate of parasite clearance. The parasite clearance rate in response to ACTs is getting slower in western Cambodia and may be the first sign of ACT resistance. Researchers want to study how effective ACTs are in different regions of Cambodia. This study will look at the extent of ACT resistance and how widespread ACT-resistant malaria has become.
Objectives:
- To compare the prevalence of ACT-resistant malaria in western, northern and eastern Cambodia.
Eligibility:
- Individuals between 2 and 65 years of age who have uncomplicated Plasmodium falciparum malaria and have not taken any antimalarial drugs for their symptoms in the previous 7 days.
Design:
- Participants will be recruited from clinics and hospitals in three Cambodian provinces.
- Participants will be informed about the study and their consent to participate in the study will be obtained.
- A venous blood sample will be obtained from patients before treatment and used for laboratory experiments to measure parasite and patient factors that might affect the parasite clearance rate.
- Participants with malaria will be treated with dihydroartemisinin-piperaquine (DHA-PPQ), the standard first-line treatment for malaria in Cambodia.
- Treatment will be monitored with frequent blood samples obtained from a finger prick. The amount of malaria parasites in each blood sample will be counted and followed until they are no longer detectable.
- Participants will have weekly follow-up visits for up to 9 weeks. Finger-prick blood samples will be taken at each visit to see if the parasites reappear after treatment with ACT.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Phnom Penh, Camboya
- National Center for Parasitology, Entomology, and Malaria Controk, Ministry of H
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
INCLUSION CRITERIA (Parasite Recrudescence Study):
- Age 2 to 65 years, inclusive
- Uncomplicated P. falciparum malaria
- Temperature greater than or equal to 37.5 degrees Celsius or history of fever within the last 24 h
- P. falciparum asexual parasite density less than or equal to 200,000/microL
- Willingness to allow the storage of blood samples collected as part of the study
- Willingness and ability of patients/guardians to comply with the protocol for the duration of the study.
EXCLUSION CRITERIA (Parasite Recrudescence Study):
- Severe malaria: diminished consciousness, respiratory distress, severe prostration, anuria, jaundice, hemoglobinuria, repetitive vomiting, or cessation of eating and drinking
- Non-malaria etiology of febrile illness (e.g., respiratory tract infection) evident by history and physical examination
- Hematocrit <25%
- Treatment of present symptoms with an antimalarial drug within the previous 7 days
- Pregnancy or breastfeeding
- History of allergy or known contraindication to artemisinins or MQ
- Splenectomy
- P. vivax parasitemia
INCLUSION CRITERIA (Peripheral Blood Collection Study):
- Healthy-appearing adults greater than or equal to 18 years old
- Residence in Pursat province
- Willingness to participate in the study as evidenced by informed consent
EXCLUSION CRITERIA (Peripheral Blood Collection Study):
- Pregnancy
- Hematocrit <25%
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Colaboradores e Investigadores
Publicaciones y enlaces útiles
Publicaciones Generales
- Dondorp AM, Nosten F, Yi P, Das D, Phyo AP, Tarning J, Lwin KM, Ariey F, Hanpithakpong W, Lee SJ, Ringwald P, Silamut K, Imwong M, Chotivanich K, Lim P, Herdman T, An SS, Yeung S, Singhasivanon P, Day NP, Lindegardh N, Socheat D, White NJ. Artemisinin resistance in Plasmodium falciparum malaria. N Engl J Med. 2009 Jul 30;361(5):455-67. doi: 10.1056/NEJMoa0808859. Erratum In: N Engl J Med. 2009 Oct 22;361(17):1714.
- Phyo AP, Nkhoma S, Stepniewska K, Ashley EA, Nair S, McGready R, ler Moo C, Al-Saai S, Dondorp AM, Lwin KM, Singhasivanon P, Day NP, White NJ, Anderson TJ, Nosten F. Emergence of artemisinin-resistant malaria on the western border of Thailand: a longitudinal study. Lancet. 2012 May 26;379(9830):1960-6. doi: 10.1016/S0140-6736(12)60484-X. Epub 2012 Apr 5.
- Witkowski B, Amaratunga C, Khim N, Sreng S, Chim P, Kim S, Lim P, Mao S, Sopha C, Sam B, Anderson JM, Duong S, Chuor CM, Taylor WR, Suon S, Mercereau-Puijalon O, Fairhurst RM, Menard D. Novel phenotypic assays for the detection of artemisinin-resistant Plasmodium falciparum malaria in Cambodia: in-vitro and ex-vivo drug-response studies. Lancet Infect Dis. 2013 Dec;13(12):1043-9. doi: 10.1016/S1473-3099(13)70252-4. Epub 2013 Sep 11.
- White NJ. The parasite clearance curve. Malar J. 2011 Sep 22;10:278. doi: 10.1186/1475-2875-10-278.
- Amaratunga C, Lim P, Suon S, Sreng S, Mao S, Sopha C, Sam B, Dek D, Try V, Amato R, Blessborn D, Song L, Tullo GS, Fay MP, Anderson JM, Tarning J, Fairhurst RM. Dihydroartemisinin-piperaquine resistance in Plasmodium falciparum malaria in Cambodia: a multisite prospective cohort study. Lancet Infect Dis. 2016 Mar;16(3):357-65. doi: 10.1016/S1473-3099(15)00487-9. Epub 2016 Jan 8.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 999912163
- 12-I-N163
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