A randomized controlled trial of azithromycin and sulphadoxine-pyrimethamine as prophylaxis against malaria in pregnancy among human immunodeficiency virus-positive women.
Adult
Anti-Bacterial Agents
/ therapeutic use
Antimalarials
/ therapeutic use
Azithromycin
/ therapeutic use
Drug Combinations
Drug Therapy, Combination
Female
HIV Seropositivity
Humans
Malaria
/ epidemiology
Nigeria
/ epidemiology
Parasitemia
/ drug therapy
Pregnancy
Pregnancy Complications, Parasitic
/ epidemiology
Pyrimethamine
/ therapeutic use
Sulfadoxine
/ therapeutic use
HIV pregnancy
azithromycin
intermittent preventive therapy
malaria in pregnancy
malaria prophylaxis
sulphadoxine–pyrimethamine
Journal
Transactions of the Royal Society of Tropical Medicine and Hygiene
ISSN: 1878-3503
Titre abrégé: Trans R Soc Trop Med Hyg
Pays: England
ID NLM: 7506129
Informations de publication
Date de publication:
01 08 2019
01 08 2019
Historique:
received:
08
11
2018
revised:
14
02
2019
pubmed:
30
5
2019
medline:
21
8
2020
entrez:
30
5
2019
Statut:
ppublish
Résumé
Malaria and human immunodeficiency virus (HIV) infections in pregnancy are important and major contributing factors to maternal morbidity and mortality in sub-Saharan Africa. Prevention of malaria in HIV-positive pregnant woman will reduce the burden of malaria-HIV comorbidity. The objective of this study was to compare effects and safety of azithromycin (AZ) with sulphadoxine-pyrimethamine (SP) for intermittent preventive therapy for malaria in HIV-positive pregnant women. We performed a randomized, controlled, open-label pregnancy trial of 140 HIV-positive pregnant patients attending antenatal clinics at the University College Hospital and Adeoyo Maternity Teaching Hospital, Ibadan, Nigeria. Participants were enrolled from a gestational age of 16 weeks and randomized to receive AZ or SP. The primary outcome was peripheral parasitaemia at delivery. Secondary outcomes were drug tolerability, foetal outcome and birthweight. The χ2 test (or Fisher's exact test, as appropriate) and Student's t test were used in the per-protocol analysis. The level of statistical significance was p<0.05. A total of 123 participants (87.9%) completed the study: 60 participants received AZ and 63 received SP. The incidence of malaria parasitaemia at delivery in the AZ group was 6 (10.0%), compared with 7 (11.1%) in the SP group (relative risk 0.89 [95% confidence interval 0.28 to 2.82], p=0.84). Placental parasitization was demonstrated in 1 (1.6%) participant in the SP group compared with 3 (5.0%) in the AZ group (p=0.36). The findings suggest that AZ is comparable to SP in malaria prevention and safety in HIV-positive pregnant women.
Sections du résumé
BACKGROUND
Malaria and human immunodeficiency virus (HIV) infections in pregnancy are important and major contributing factors to maternal morbidity and mortality in sub-Saharan Africa. Prevention of malaria in HIV-positive pregnant woman will reduce the burden of malaria-HIV comorbidity. The objective of this study was to compare effects and safety of azithromycin (AZ) with sulphadoxine-pyrimethamine (SP) for intermittent preventive therapy for malaria in HIV-positive pregnant women.
METHODS
We performed a randomized, controlled, open-label pregnancy trial of 140 HIV-positive pregnant patients attending antenatal clinics at the University College Hospital and Adeoyo Maternity Teaching Hospital, Ibadan, Nigeria. Participants were enrolled from a gestational age of 16 weeks and randomized to receive AZ or SP. The primary outcome was peripheral parasitaemia at delivery. Secondary outcomes were drug tolerability, foetal outcome and birthweight. The χ2 test (or Fisher's exact test, as appropriate) and Student's t test were used in the per-protocol analysis. The level of statistical significance was p<0.05.
RESULTS
A total of 123 participants (87.9%) completed the study: 60 participants received AZ and 63 received SP. The incidence of malaria parasitaemia at delivery in the AZ group was 6 (10.0%), compared with 7 (11.1%) in the SP group (relative risk 0.89 [95% confidence interval 0.28 to 2.82], p=0.84). Placental parasitization was demonstrated in 1 (1.6%) participant in the SP group compared with 3 (5.0%) in the AZ group (p=0.36).
CONCLUSIONS
The findings suggest that AZ is comparable to SP in malaria prevention and safety in HIV-positive pregnant women.
Identifiants
pubmed: 31140565
pii: 5505394
doi: 10.1093/trstmh/trz028
doi:
Substances chimiques
Anti-Bacterial Agents
0
Antimalarials
0
Drug Combinations
0
fanasil, pyrimethamine drug combination
37338-39-9
Azithromycin
83905-01-5
Sulfadoxine
88463U4SM5
Pyrimethamine
Z3614QOX8W
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
463-470Informations de copyright
© The Author(s) 2019. Published by Oxford University Press on behalf of Royal Society of Tropical Medicine and Hygiene. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.