Chloroquine prophylaxis against vivax malaria in pregnancy: a randomized, double‐blind, placebo‐controlled trial

• Published in: Tropical medicine & international health 2007-02, Vol.12 (2), p.209-218
• Main Authors: Villegas, Leopoldo, McGready, Rose, Htway, Mg, Paw, Moo Kho, Pimanpanarak, Mupawjay, Arunjerdja, Ratree, Viladpai‐nguen, Samuel Jacher, Greenwood, Brian, White, Nicholas J, Nosten, François
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Anemia - complications; Anemia - epidemiology; Antimalarials - adverse effects; Antimalarials - therapeutic use; Biological and medical sciences; Child Development; chloroquine; Chloroquine - adverse effects; Chloroquine - analogs & derivatives; Chloroquine - therapeutic use; Clinical trials; cloroquina; Double-Blind Method; embarazo; Female; General aspects; grossesse; Human protozoal diseases; Humans; Infant; Infectious diseases; Malaria; Malaria, Falciparum - epidemiology; Malaria, Falciparum - prevention & control; Malaria, Vivax - epidemiology; Malaria, Vivax - parasitology; Malaria, Vivax - prevention & control; Medical sciences; Middle Aged; P. vivax; Parasitemia - prevention & control; Parasitic diseases; Patient safety; Pharmacology; Plasmodium falciparum; Plasmodium vivax; Pregnancy; Pregnancy Complications, Infectious - epidemiology; Pregnancy Complications, Infectious - parasitology; Pregnancy Complications, Infectious - prevention & control; Pregnancy Outcome; Prenatal care; Preventive medicine; profilaxis para P. vivax; Prophylaxie P. vivax; Protozoal diseases; Sus; Tailandia; Thailand; Thailand - epidemiology; Thaïlande; Treatment Outcome
• ISSN: 1360-2276; 1365-3156
• DOI: 10.1111/j.1365-3156.2006.01778.x

Summary Objective  To assess the safety of chloroquine (CQ) as prophylaxis against Plasmodium vivax infection during pregnancy. Method  One thousand pregnant Karen women were enrolled in a randomized, double‐blind, placebo‐controlled trial of chemoprophylaxis with chloroquine (500 mg phosphate (or 300 mg base) weekly). Women received a median (range) chloroquine phosphate total dose of 9500 (1500–17 500) mg. The mothers were actively followed from inclusion to delivery and their infants until 12 months of age. Results  Chloroquine prophylaxis completely prevented P. vivax episodes; 10.1% (95%CI: 7.3–14.5) of women in the placebo group experienced at least one episode of vivax malaria but no episode occurred in women in the CQ group. By contrast, the numbers of P. falciparum episodes were similar in each group: 7.4% (95%CI: 3.7–11.1) and 5.6% (95%CI: 3.3–7.9) in the placebo and CQ groups respectively (P = 0.56). Chloroquine prophylaxis was well tolerated and there was no difference in the proportions of reported side effects between CQ treated and placebo groups except for the duration of palpitations and sleeping disorders which were more frequent in those who had received CQ. Chloroquine prophylaxis had no impact on maternal anaemia, birth weight, gestational age, development of newborns or on growth, neurological development or visual acuity in infants at 1 year of age. Conclusion  Chloroquine is safe and effective as prophylaxis against P. vivax during pregnancy in this population. Objectif  Evaluer la sûreté de la chloroquine comme prophylaxie contre l'infection de P. vivax pendant la grossesse. Méthode  Mille femmes enceintes Karen ont été enrôlées dans une étude randomisée placebo/contrôle à double aveugle sur la chimioprophylaxie avec la chloroquine (500 mg de chloroquine sulfate ou 300 mg de chloroquine base hebdomadaire). Les femmes ont reçu une dose médiane de phosphate de chloroquine de 9500 [1500–17 500] mg. Les mères ont été activement suivies de inclusion jusqu’à l'accouchement et à leur enfants jusqu ’à l’âge de 12 mois. Résultats  La prophylaxie à chloroquine a complètement évité les épisodes de P. vivax. 10,1% (IC 95%: 7,3–14,5) des femmes dans le groupe placebo ont eu au moins un épisode de vivax mais aucun épisode n'a été observé chez les femmes dans le groupe chloroquine. En revanche, le nombre d’épisodes de malaria àP. falciparuméta similaire dans les deux groupes: 7,4% (IC95%: 3,7–11,1) et 5,6% (IC95%: 3,3–7,9) dans les groupes placeb