PMID- 28511713
OWN - NLM
STAT- MEDLINE
DCOM- 20180119
LR  - 20220129
IS  - 1475-2875 (Electronic)
IS  - 1475-2875 (Linking)
VI  - 16
IP  - 1
DP  - 2017 May 16
TI  - Artemisinin-based combination therapy in pregnant women in Zambia: efficacy, 
      safety and risk of recurrent malaria.
PG  - 199
LID - 10.1186/s12936-017-1851-7 [doi]
LID - 199
AB  - BACKGROUND: In Zambia, malaria is one of the leading causes of morbidity and 
      mortality, especially among under five children and pregnant women. For the 
      latter, the World Health Organization recommends the use of artemisinin-based 
      combination therapy (ACT) in the second and third trimester of pregnancy. In a 
      context of limited information on ACT, the safety and efficacy of three 
      combinations, namely artemether-lumefantrine (AL), mefloquine-artesunate (MQAS) 
      and dihydroartemisinin-piperaquine (DHAPQ) were assessed in pregnant women with 
      malaria. METHODS: The trial was carried out between July 2010 and August 2013 in 
      Nchelenge district, Luapula Province, an area of high transmission, as part of a 
      multi-centre trial. Women in the second or third trimester of pregnancy and with 
      malaria were recruited and randomized to one of the three study arms. Women were 
      actively followed up for 63 days, and then at delivery and 1 year post-delivery. 
      RESULTS: Nine hundred pregnant women were included, 300 per arm. PCR-adjusted 
      treatment failure was 4.7% (12/258) (95% CI 2.7-8.0) for AL, 1.3% (3/235) (95% CI 
      0.4-3.7) for MQAS and 0.8% (2/236) (95% CI 0.2-3.0) for DHAPQ, with significant 
      risk difference between AL and DHAPQ (p = 0.01) and between AL and MQAS 
      (p = 0.03) treatments. Re-infections during follow up were more frequent in the 
      AL (HR: 4.71; 95% CI 3.10-7.2; p < 0.01) and MQAS (HR: 1.59; 95% CI 1.02-2.46; 
      p = 0.04) arms compared to the DHAPQ arm. PCR-adjusted treatment failure was 
      significantly associated with women under 20 years [Hazard Ratio (HR) 5.35 (95% 
      CI 1.07-26.73; p = 0.04)] and higher malaria parasite density [3.23 (95% CI 
      1.03-10.10; p = 0.04)], and still women under 20 years [1.78, (95% CI 1.26-2.52; 
      p < 0.01)] had a significantly higher risk of re-infection. The three treatments 
      were generally well tolerated. Dizziness, nausea, vomiting, headache and asthenia 
      as adverse events (AEs) were more common in MQAS than in AL or DHAPQ (p < 0.001). 
      Birth outcomes were not significantly different between treatment arms. 
      CONCLUSION: As new infections can be prevented by a long acting partner drug to 
      the artemisinins, DHAPQ should be preferred in places as Nchelenge district where 
      transmission is intense while in areas of low transmission intensity AL or MQAS 
      may be used.
FAU - Nambozi, Michael
AU  - Nambozi M
AUID- ORCID: 0000-0002-0369-0970
AD  - Department of Clinical Sciences, Tropical Diseases Research Centre, P.O Box 
      71769, Ndola, Zambia. michaelnambozi@yahoo.com.
FAU - Kabuya, Jean-Bertin Bukasa
AU  - Kabuya JB
AD  - Department of Clinical Sciences, Tropical Diseases Research Centre, P.O Box 
      71769, Ndola, Zambia.
FAU - Hachizovu, Sebastian
AU  - Hachizovu S
AD  - Department of Clinical Sciences, Tropical Diseases Research Centre, P.O Box 
      71769, Ndola, Zambia.
FAU - Mwakazanga, David
AU  - Mwakazanga D
AD  - Department of Clinical Sciences, Tropical Diseases Research Centre, P.O Box 
      71769, Ndola, Zambia.
FAU - Mulenga, Joyce
AU  - Mulenga J
AD  - Department of Clinical Sciences, Tropical Diseases Research Centre, P.O Box 
      71769, Ndola, Zambia.
FAU - Kasongo, Webster
AU  - Kasongo W
AD  - Department of Clinical Sciences, Tropical Diseases Research Centre, P.O Box 
      71769, Ndola, Zambia.
FAU - Buyze, Jozefien
AU  - Buyze J
AD  - Institute of Tropical Medicine, Antwerp, Belgium.
FAU - Mulenga, Modest
AU  - Mulenga M
AD  - Department of Clinical Sciences, Tropical Diseases Research Centre, P.O Box 
      71769, Ndola, Zambia.
FAU - Van Geertruyden, Jean-Pierre
AU  - Van Geertruyden JP
AD  - Global Health Institute, University of Antwerp, Antwerp, Belgium.
FAU - D'Alessandro, Umberto
AU  - D'Alessandro U
AD  - Institute of Tropical Medicine, Antwerp, Belgium.
AD  - Medical Research Council Unit, Serekunda, Gambia.
AD  - London School of Hygiene and Tropical Medicine, London, UK.
LA  - eng
GR  - MC_UP_A900_1119/MRC_/Medical Research Council/United Kingdom
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20170516
PL  - England
TA  - Malar J
JT  - Malaria journal
JID - 101139802
RN  - 0 (Antimalarials)
RN  - 0 (Artemether, Lumefantrine Drug Combination)
RN  - 0 (Artemisinins)
RN  - 0 (Drug Combinations)
RN  - 0 (Ethanolamines)
RN  - 0 (Fluorenes)
RN  - 0 (Quinolines)
RN  - 60W3249T9M (Artesunate)
RN  - 6A9O50735X (artenimol)
RN  - A0HV2Q956Y (piperaquine)
RN  - TML814419R (Mefloquine)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Antimalarials/*therapeutic use
MH  - Artemether, Lumefantrine Drug Combination
MH  - Artemisinins/*therapeutic use
MH  - Artesunate
MH  - Drug Combinations
MH  - Ethanolamines/therapeutic use
MH  - Female
MH  - Fluorenes/therapeutic use
MH  - Humans
MH  - Malaria/*drug therapy/parasitology
MH  - Mefloquine/therapeutic use
MH  - Pregnancy
MH  - Quinolines/therapeutic use
MH  - Recurrence
MH  - Risk
MH  - Treatment Outcome
MH  - Young Adult
MH  - Zambia
PMC - PMC5434531
OTO - NOTNLM
OT  - Africa
OT  - Artemisinin-combination therapy
OT  - Sub-Saharan
OT  - Treatment failure
OT  - Zambia
EDAT- 2017/05/18 06:00
MHDA- 2018/01/20 06:00
PMCR- 2017/05/16
CRDT- 2017/05/18 06:00
PHST- 2016/12/22 00:00 [received]
PHST- 2017/05/09 00:00 [accepted]
PHST- 2017/05/18 06:00 [entrez]
PHST- 2017/05/18 06:00 [pubmed]
PHST- 2018/01/20 06:00 [medline]
PHST- 2017/05/16 00:00 [pmc-release]
AID - 10.1186/s12936-017-1851-7 [pii]
AID - 1851 [pii]
AID - 10.1186/s12936-017-1851-7 [doi]
PST - epublish
SO  - Malar J. 2017 May 16;16(1):199. doi: 10.1186/s12936-017-1851-7.