Health Condition 1: null- This study will be conducted with symptomatic or asymptomatic uncomplicated falciparum malaria in 2nd and 3rd trimester during pregnancy
Conditions
Interventions
Intervention1: 1.Artesunate 200mg x 3 days + mefloquine 440mg x 3 days.: Oral route
Artesunate 200mg on day1 mefloquine 440mg on day1
Artesunate 200mg on day2 mefloquine 440mg on day2
Artesunate 200mg
Sponsors
Malaria in Pregnancy Consortium Liverpool School of Tropical Medicine Liverpool UK
Eligibility
Inclusion criteria
Inclusion criteria: (i) Pregnant women of all parities having P falciparum parasitaemia (mono infection)in 2nd and 3rd trimester
Exclusion criteria
Exclusion criteria: (i) Hb <7; (ii) gestation <12 or >36 wks; (iii) age <18 years (iv) abnormal liver or renal function; (v) history of taking an antimalarial within the last 7 days; (vi) history of allergy to any of the study drugs; (vii) taking part in any other clinical trials of drugs or vaccines; (viii) severe malaria (based either on clinical presentation or parasitological grounds); (ix) Other conditions requiring hospitalization or evidence of severe concomitant infection; (x) Known chronic disease (cardiac, haemoglobinopathy); (xi) History of convulsions during the present illness or history of psychiatric disorder or seizures (xii) vivax malaria or mixed infection Inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adequate clinical and parasitological response corrected for new infections by PCR by day 63 post treatment (ACPR63)Timepoint: Day 63 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Adverse events both clinical and biochemical 2.Birth outcomes 3.Re-infection by day 63 4.Congenital malformations detected within 7 days of birth Timepoint: Birth outcomes and followup upto 42 days | — |
Countries
India
Contacts
Public ContactDr Anupkumar Anvikar
Outcome results
None listed