An observational study in Plasmodium Falciparum and Plasmodium Vivax, sponsored by University of Oxford. Status unknown at 3 sites in 3 countries. Per ClinicalTrials.gov, last updated 2022-03-23.
Sponsored by University of Oxford · Observational
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Among 54 studies in Malaria, Falciparum by University of Oxford — 3 open to participants now, 9 under way, 1 of them phase 3. Malaria, Falciparum · University of Oxford.
Among the 54 studies in Malaria, Falciparum by University of Oxford, this one is one of 2 that started in 2016, is one of 7 observational ones, and was the 22nd registered.
456 studies on the registry are indexed under Malaria, Falciparum; 38 are open to participants now.
Browse Malaria, Falciparum studies →3 of the 54 studies in Malaria, Falciparum by University of Oxford are open now, in 2 countries. Recruiting first, the newest first:
University of Oxford · Sites in Rwanda
Ages 6 mo+
University of Oxford · Sites in Bangladesh
Ages 6 mo+
University of Oxford · Sites in Bangladesh
Ages 14–60 · Healthy volunteers
By country, each count listing its studies:
Of the 22 Malaria, Falciparum studies recruiting now, 6 (27%) set no upper age limit and 15 (68%) stop at 75 or younger; 14 take children under 18; 9 take healthy volunteers.
This study: all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
54 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 23 · Phase 2 19 · Phase 3 10 · Phase 4 3
First in 2005; this study’s year is marked. 2 started in 2016.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 30,000 is above the median of 579 across 64 observational studies indexed under Malaria, Falciparum.
Median enrollment 62 across the 47 interventional studies, 399 across the 7 observational. Of the 42 that completed or were terminated, 4 (10%) have results posted.
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University of Oxford is the lead sponsor of 813 studies on the registry; 120 are open to participants now.
4 of the studies in Malaria, Falciparum by University of Oxford that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07194668University of OxfordR21/MM Dosing, Presentations, and Preservatives | 2026-12-31 |
| NCT06958198University of OxfordA Study to Assess the Experimental Malaria Vaccines R78C and RH5.1 Combined With R21/Matrix-M (a "Multi-stage" Malaria Vaccine) | 2027-03 |
| NCT07183371University of OxfordA Study to Assess the Experimental Malaria Vaccines R78C and RH5.1 With Matrix-M in Combination With R21/Matrix-M | 2027-03 |
| NCT07074665University of OxfordDose Finding Trial of R21/Matrix-M in School Children | 2027-03 |
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Among the 54 studies in Malaria, Falciparum by University of Oxford, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study is to determine the prevalence and geographical distribution of antimalarial drug resistance-linked genetic mutations in clinical P. falciparum and/or P.Vivax infection in the Greater Mekong Subregion
This is a prospective observational study of patients with clinical Plasmodium falciparum and/or Plasmodium Viviax infection using parasite DNA from point-of-care fingerprick dried blood spot samples as well as a short survey on patient demographics, employment, travel, and mobile phone use to study P. falciparum parasite genotypes, population characteristics, and gene flow patterns.
On inclusion in the study and before standard treatment is administered, dried blood spots (DBS) will be obtained through fingerprick blood sampling from patients, with two or three blood spots on one piece of filter paper being obtained from each patient. Each blood spot will contain \~20µl of blood, for a total of \~ 40-60 uL of blood being collected from each patient for the study.
In order to have a greater understanding of the possible sites of malaria transmission and to relate genetic diversity to geographic location, patients or their parents/guardians will also be asked a short set of questions on demographics, their places of residence and work, recent mobile phone use, and their history of travel. The basic questions on phone utilisation will provide information on the use of mobile phones in the study population, including which mobile phone companies are used, and how many SIM cards and handsets each person carries. It will be employed to derive information on population movement from anonymised, aggregated data on mobile phone telephone use, i.e. call detail records (CDR), obtained from mobile phone companies in each country. This will be used for the modelling of population movement, its impact on the distribution of malaria and antimalarial drug resistance, and subsequent prediction of potential routes of spread of malaria and antimalarial drug resistance. As some of this information can be sensitive, during the consent process the patient will be given the option of not providing some or all of this information without needing to provide a reason. For those who do not wish to provide information, this will be documented in the survey form. A duplicate of the sample barcode will be placed on this same form, so the information therein can be matched with the relevant blood spot and its related genetic data, while retaining sample anonymity.
All patients in the study will receive standard care for falciparum malaria including drug therapy according to the national treatment guidelines of their country.
Patients of all ages with P. falciparum and/or P.Vivax malaria who present to participating health facilities in Vietnam, Cambodia, Lao PDR, Thailand and Myanmar are the target study population.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Annual maps and reports on the prevalence of drug resistance-linked genetic mutations in P. falciparum parasites in the Greater Mekong Subregion
Time frame: up to 12 months
Allelic variations associated to drug resistance in P. falciparum at the locations surveyed
By using genotypes produced by high-throughput techniques (sequencing, PCR, mass spectrometry etc.).
Time frame: up to 12 months
Allelic variations associated to drug resistance in P. vivax at the locations surveyed
By using genotypes produced by high-throughput techniques (sequencing, PCR, mass spectrometry etc.).
Time frame: up to 12 months
Genetic differentiation between parasites populations at different locations in the Greater Mekong Subregion
By using population genetic measures such as FST and allele frequencies
Time frame: up to 12 months
Population structure of parasites
By using population genetics and clustering techniques, such as Principal Component Analysis and phylogeny
Time frame: up to 12 months
Gene flow patterns of P. falciparum malaria parasites in the Greater Mekong Subregion
Time frame: up to 12 months
Likely geographic origin of P. falciparum malaria parasites in the Greater Mekong Subregion
Time frame: up to 12 months
Plan to share: Yes
No publications or documents are linked to this record.
Started Oct 2016 (actual). Primary completion is estimated for Jan 2023, 75 months after the start.
Of 20 observational studies under Malaria, Falciparum, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 43. This study's planned 75 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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