Table 2.
Study enrolment | Routine visit 1 | Routine visit 2 | qPCR results reported | Post-treatment visit 1 | Post-treatment visit 2 | |
---|---|---|---|---|---|---|
Timeline | ||||||
Date | 22/12/2015 | 13/02/2016 | 13/04/2016 | 28/04/2016 | 06/05/2016 | 01/07/2016 |
Days respective to enrolment into clinical trial | 0 | 53 | 113 | 128 | 136 | 192 |
Clinical evaluation | ||||||
Body temperature | 36.5 °C | 36.8 °C | 36.7 °C | 36.6 °C | – | 36.4 °C |
Vital signs including pulse, blood pressure and respiration rate | NAD | NAD | NAD | NAD | – | NAD |
Laboratory evaluation | ||||||
Biochemistry including ALT, AST | NAD, also included BIL and CRE at enrolment | NAD | NAD | NAD | – | NAD |
Complete blood count includes RBC, HGB, HCT, MCV, MCH, MCHC, PLT, WBC with differential | EO ↑ (1.19 × 103/µL, 18.1%) | EO ↑ (1.04 × 103/µL, 17.2%) | EO ↑ (1.06 × 103/µL, 12.0%) RDW-SD ↓ (34.4 fL) | EO ↑ (0.63 × 103/µL, 6.5%) WBC ↑ (9.65 × 103/µL) NEUT ↑ (6.07 × 103/µL, 62.9%) |
– | EO ↑ (0.77 × 103/µL, 12.0%) RDW-SD ↓ (33.6 fL) |
Urine analysis using dipstick that includes bilirubin, ketone, creatinine, hematuria, proteinuria, albumin, nitrite, leucocytes, glucose, specific gravity, pH, vitamin C | NAD | NAD | NAD | NAD | – | Proteinuria (trace) |
Serology (HIV, HBV, HCV) | Negative | – | – | – | – | – |
Screening for intestinal helminths and schistosomiasis | Negative | – | – | – | – | – |
Malaria diagnostics | ||||||
Thick blood smear microscopy | Negative | Negative | Negative | Negative | Negative | Negative |
Screening and species identification qPCR assays | Screening qPCR: Cq of 31.62 ID-qPCR: P. malariae | Screening qPCR: Cq of 32.78 ID-qPCR: P. malariae | Screening qPCR: Cq of 33.44 ID-qPCR: P. malariae | Screening qPCR: Cq of 34.47 ID-qPCR: P. malariae | Screening qPCR: neg | Screening qPCR: neg |
Drug treatment | ||||||
Prescription of drugs throughout the clinical trial | – | – | – | Start of artesunate-amodiaquine based treatment on 02/05/2016 | – | – |
NAD no abnormalities detected