Table 1.
Overview of clinical and parasitological parameters assessed for volunteer 1
| 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 | 36.6 °C | 36.2 °C | 36.8 °C | 36.6 °C | – | 37.2 °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 | NAD | NEUT ↑ (3.57 × 103/µL, 72.2%) LYMP ↓ (0.70 × 103/µL, 14.1%) |
MCHC ↓ (29.7 g/dL) | NAD | – | NAD |
| Urine analysis using dipstick that includes bilirubin, ketone, creatinine, hematuria, proteinuria, albumin, nitrite, leucocytes, glucose, specific gravity, pH, vitamin C | NAD | NAD | Proteinuria (1+) | NAD | – | NAD |
| 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 36.03 ID-qPCR: P. malariae | Screening qPCR: Cq of 35.72 ID-qPCR: P. malariae | Screening qPCR: Cq of 37.69 ID-qPCR: nega | 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
aPlasmodium species identification qPCR assay was negative due to drop of P. malariae parasitemia (Cq value for 18S Plasmodium spp. screening assay was 37.69)