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Table 2 Table of times and events for adults and children over 12 years of age

From: Cluster-randomized trial of monthly malaria prophylaxis versus focused screening and treatment: a study protocol to define malaria elimination strategies in Cambodia

Event Screen/enroll day 1 Day 33 Day 307 Day 607 Day 907 Day 1207 Day 1507 Day 1807 Malaria diagnosis/ recurrence2
a. Informed consent X         
b. Medical history X         
c. Physical exam X         X
d. Brief clinical evaluation and vital signs1    X X X X X X X
e. Malaria RDT, DBS, smear and PCR genotyping6 2 mL   1.5 1.5 1.5 1.5 1.5 1.5 1.5 mL
i. CBC 1 mL 1 mL3        
k. Molecular resistance markers2          6 mL
l. G6PD RDT, fluorescent spot, quantitative testing 1.5 mL         
m. Gametocyte PCR 2.5 mL   2.5 2.5 2.5 2.5 2.5 2.5 2.5 mL
n. Urine pregnancy test (women of child-bearing age) X   X X      X
o. Malaria treatment4,5 X   X X      X
Daily phlebotomy (mL) 7 13 4 4 4 4 4 4 10
Cumulative phlebotomy (approximately mL) 7   11 15 19 23 27 31 41
  1. 1Brief clinical evaluation includes an interval medical history, vital signs and a directed physical exam as indicated
  2. 2Performed only for volunteers with smear-positive malaria. Those with PCR-positive malaria will be treated following national guidelines but will not have blood drawn for molecular markers of resistance
  3. 3To be drawn for G6PD-deficient volunteers only. All G6PD-deficient volunteers with > 10% of Hgb or HTC drop on D3 will have CBC on day 7
  4. 4Patients screening positive on microscopy and/or PCR for P. falciparum malaria in the FSAT arm will receive currently recommended blood-stage antimalarials under published national treatment guidelines as well as single, low-dose primaquine (15 mg). Volunteers with P. vivax will be treated with the currently recommended blood-stage agent (DHA-PIP), as well as primaquine – G6PD-normal volunteers will receive 15 mg daily for 14 days, while G6PD-deficient volunteer will receive 45 mg × 8 weeks. All volunteers in the MMP arm will receive a fixed-dose 3-day course of DHA-piperaquine at 0, 24 and 48 h starting on days 1, 30, and 60, and a weekly 22.5-mg dose of primaquine for 12 weeks. All therapy will be directly observed
  5. 5For all volunteers with recurrent malaria, rescue therapy will be with the recommended agent(s) per national guidelines
  6. 6May be repeated as medically indicated (e.g., if patient is malaria-positive or otherwise ill on enrollment). An additional 0.5 mL will be collected on the day of enrollment for baseline G6PD genotyping
  7. 7Time window of ± 7 days
  8. CBC complete blood count, DBS dried blood spot, DHA-PIP dihydroartemisinin-piperaquine, G6PD glucose-6-phosphatase dehydrogenase, Hgb hemoglobin, PCR polymerase chain reaction, RDT rapid diagnostic test
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Trials

ISSN: 1745-6215