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Plasmodium Falciparum MalariaNCT01736319

Artemisinin-resistant Malaria in Cambodia

An observational study of Plasmodium Falciparum Malaria, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Cambodia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 2 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Plasmodium Falciparum Malaria
How many people
561 participants
Where
1 siteCambodia
Study dates
26 Jun 2012to 6 Apr 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • Splenectomy
  • P. vivax parasitemia
  • Pregnancy
  • Hematocrit <25%

Trial locations and contacts

1 site in 1 country.

Cambodia1 site

  • National Center for Parasitology, Entomology, and Malaria Controk, Ministry of H

    Phnom Penh

Other trials in Cambodia

About this study

Official title: 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.
Read more

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.
Read the detailed description

Artemisinin-based combination therapies (ACTs) are the first-line treatments for Plasmodium falciparum malaria worldwide. In Western Cambodia,artemisinin resistance has been defined as a long half-life of parasite clearance (T1/2) in response to an artemisinin, given orally for uncomplicated malaria. We hypothesize that this artemisinin resistance phenotype compromises the efficacy of ACTs. The primary objective of this study is to compare P. falciparum recrudescence rates in Western, Northern and Eastern Cambodia, following dihydroartemisinin-piperaquine (DHA-PPQ) treatment. The secondary objective of this study is to determine whether parasite recrudescence is associated with long T1/2. In the Parasite Recrudescence Study, patients with uncomplicated malaria will receive directly-observed treatment with DHA-PPQ over 3 days. We will follow these patients weekly for 9 weeks to identify those with recurrent parasitemia and use genotyping methods to distinguish recrudescences from reinfections. We will enroll a subset of these patients who have an initial parasite density greater than or equal to 10,000/microL in the Parasite Clearance Rate Study and follow their parasite densities more intensively by examining 6-hourly finger prick blood samples until parasites are undetectable by microscopy. With these data we will calculate and compare T1/2 values from patients with and without recrudescent parasitemia. Using various laboratory assays, we will also explore the contribution of host factors to T1/2 variation, and whether naturally-acquired immunity reduces the risk of drug-resistant parasite recrudescence.

Keywords
Artemisinin-based Combination Therapies, Recrudescence, DHA-PPQ, Parasite Clearance Rate
Medical subject headings
Malaria, Falciparum, Recurrence

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2012 (estimated)
  2. Study start26 Jun 2012
  3. Study completion6 Apr 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Prospective
Enrolment
561 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01736319
Sponsor's protocol ID
999912163
Other IDs
12-I-N163
Status last verified
6 Apr 2016
First submitted
27 Nov 2012
Last updated
1 Jun 2018
Results posted
No

Publications

  • 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.

    PubMed 19641202

  • 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.

    PubMed 22484134

  • White NJ. The parasite clearance curve. Malar J. 2011 Sep 22;10:278. doi: 10.1186/1475-2875-10-278.

    PubMed 21939506

  • 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.

    PubMed 26774243

  • 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.

    PubMed 24035558

Questions about this trial

What is this clinical trial studying?

An observational study of Plasmodium Falciparum Malaria, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Cambodia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Cambodia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01736319, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2018.

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