Prevalence Survey of Antimalarial Drug Resistance Markers

NCT03217851 | Completed

• 1 other identifier: BAKMAL 1701
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

Brief Summary

Study is cross-sectional and observational with one-time dried-blood spot sample collection from persons with laboratory-confirmed uncomplicated Plasmodium falciparum malaria (mixed or monoinfection). Samples will be analysed for the presence of molecular markers of resistance to ACT partner drugs (gene amplifications and/or other mutations in pfmdr1, gene amplifications of pfpm2, and additional mutations which may be identified during the course of the trial) in the first instance. Testing to detect additional markers of antimalarial drug resistance will also be performed where feasible. Prevalence of mutations will be summarized and mapped to provide intelligence on antimalarial drug resistance in the region of interest.

Conditions

Malaria

Keywords

Plasmodium falciparum; Prevalence Survey; Antimalarial Drug

Outcome Measures

Primary Outcomes (1)

• Prevalence and geospatial trends of molecular markers, information to assist definition of treatment policies

  3 years

Secondary Outcomes (1)

• Visualization and dissemination of molecular marker prevalence data to inform public health officials, researchers, policymakers and key stakeholders

  3 years

Study Arms (1)

Patients Presenting P. falciparum Malaria

Diagnostic Test: Blood Collection; Diagnostic Test: Dried Blood Spot

Interventions

Blood Collection DIAGNOSTIC_TEST

blood smear and/or rapid diagnostic

Patients Presenting P. falciparum Malaria

Dried Blood Spot DIAGNOSTIC_TEST

Dried Blood Spot on filter paper

Patients Presenting P. falciparum Malaria

Eligibility Criteria

• Age: 6 Months - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients age 6 months - 75 years presenting at study site with confirmed P. falciparum infection

You may qualify if:

• Patients (6 months - 75 years) with confirmed uncomplicated P. falciparum infection
• Written informed consent obtained (by parents/guardian in case of children less than 18 years old)

You may not qualify if:

• Patients presenting signs of severe malaria\* will be excluded from the survey to prevent any delay in the management of the patient.
• \*Guideline for the treatment of Malaria-3rd edition, WHO (27) Severe falciparum malaria is defined as one or more of the following, occurring in the absence of an identified alternative cause and in the presence of P.falciparum asexual parasitaemia.
• Impaired consciousness: A Glasgow comma score \< 11 in adults or Blantyre coma score \< 3 in children
• Prostration: Generalized weakness so that the person is unable to sit, stand or walk without assistance.
• Multiple convulsions: More than two episodes within 24 h
• Acidosis: A base deficit of \> 8 mEq/L or, if not available a plasma bicarbonate level of \< 15 mmol/L or venous plasma lactate ≥ 5 mmol/L. Severe acidosis manifests clinically as respiratory distress (rapid, deep, laboured breathing).
• Hypoglycaemia: Blood or plasma glucose \< 2.2 mmol/L (\<40 mg/dL)
• Severe malarial anaemia: Haemoglobin concentration ≤ 5 g/dL or a haematocrit of ≤ 15% in children \< 12 years of age (\< 7 g/dL and \< 20%, respectively, in adults) with a parasite count \> 10,000/µL
• Renal impairment: Plasma or serum creatinine \> 265 µmol/L (3 mg/dL) or blood urea \> 20 mmol/L
• Jaundice: Plasma or serum bilirubin \> 50 µmol/L (3 mg/dL) with a parasite count \> 100,000/ µL
• Pulmonary oedema: Radiologically confirmed or oxygen saturation \< 92% on room air with a respiratory rate \> 30/min, often with chest indrawing and crepitations on auscultation
• Significant bleeding: Including recurrent or prolonged bleeding from the nose, gums or venepuncture site; haematemesis or melaena
• Shock: Compensated shock is defined as capillary refill ≥ 3 s or temperature gradient on leg (mid to proximal limb), but no hypotension. Decompensated shock is defined as systolic blood pressure \< 70 mm Hg in children or \< 80 mm Hg in adults, with evidence of impaired perfusion (cool peripheries or prolonged capillary refill)
• Hyperparasitaemia: P.falciparum parasitaemia \> 10%

Sponsors & Collaborators

• University of Oxford: lead
• Mahidol University: collaborator
• Worldwide Antimalarial Resistance Network: collaborator
• Mahidol Oxford Tropical Medicine Research Unit: collaborator
• Myanmar Oxford Clinical Research Unit: collaborator
• Shoklo Malaria Research Unit: collaborator
• Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit: collaborator
• Oxford University Clinical Research Unit, Vietnam: collaborator
• Cambodia Oxford Medical Research Unit: collaborator

Study Sites (1)

Shoklo Malaria Research Unit

Mae Sot, Changwat Tak, 63110, Thailand

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Collect blood for malaria diagnostic testing (blood smear and/or rapid diagnostic test) and dried blood spot on filter paper

MeSH Terms

Conditions

Malaria; Malaria, Falciparum

Interventions

Blood Specimen Collection; Dried Blood Spot Testing

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Blood Chemical Analysis; Clinical Chemistry Tests

Study Officials

• Francois Nosten, Prof

  Shoklo Malaria Research Unit

  STUDY DIRECTOR

• Frank Smithuis, Prof

  Myanmar Oxford Clinical Research Unit

  STUDY DIRECTOR

• Mayfong Mayxay, Prof

  Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit

  PRINCIPAL INVESTIGATOR

• Nguyen Thanh Thuy Nhien, Dr

  Oxford University Clinical Research Unit, Vietnam

  PRINCIPAL INVESTIGATOR

• Arjen M. Dondorp, PhD

  Mahidol Oxford Clinical Research Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2017
• First Posted: July 14, 2017
• Study Start: September 18, 2017
• Primary Completion: December 24, 2021
• Study Completion: December 24, 2021
• Last Updated: June 28, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share

Locations

TH (1)