Evidence map›Paper›PMID 19352498›Full record

Trial reportPloS one2009

Randomized trial of artesunate+amodiaquine, sulfadoxine-pyrimethamine+amodiaquine, chlorproguanal-dapsone and SP for malaria in pregnancy in Tanzania.

Theonest K Mutabingwa, Kandi Muze, Rosalynn Ord, Marnie Briceño, Brian M Greenwood, Chris Drakeley, Christopher J M Whitty

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in PloS one, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00146731 (Treating Malaria During Pregnancy), which is not on this map. Cited by 30 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 8 pooled it
5.2field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00146731 phase3completednot on this map

Treating Malaria During Pregnancy: A Randomized Trial of Potential Options for Treatment in an Area of High Drug Resistance in Tanzania

TypeinterventionalSponsorLondon School of Hygiene and Tropical MedicineRan2004 to 2007Enrolled310ConditionsMalariaArmsSP, SP + amodiaquine, AQ + artesunate, chlorproguanil-dapsone
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 8 syntheses or guidelines pooled it, 53 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 3 institutions in 3 countries.

Theonest K MutabingwaDepartment of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, United Kingdom. tk.bingwa@yahoo.com
Kandi Muze
Rosalynn Ord
Marnie Briceño
Brian M Greenwood
Chris Drakeley
Christopher J M Whitty
London School of Hygiene & Tropical Medicine · GBMuhimbili Orthopaedic Institute · TZUniversity of Washington · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMalaria in pregnancy is serious, and drug resistance in Africa is spreading. Drugs have greater risks in pregnancy and determining the safety and efficacy of drugs in pregnancy is therefore a priority. This study set out to determine the efficacy and safety of several antimalarial drugs and combinations in pregnant women with uncomplicated malaria.

methodsPregnant women with non-severe, slide proven, falciparum malaria were randomised to one of 4 regimes: sulfadoxine-pyrimethamine [SP]; chlorproguanil-dapsone [CD]; SP+amodiaquine [SP+AQ] or amodiaquine+artesunate [AQ+AS]. Randomisation was on a 1ratio2ratio2ratio2 ratio. Women were admitted for treatment, and followed at days 7, 14, 21, 28 after the start of treatment, at delivery and 6 weeks after delivery to determine adverse events, clinical and parasitological outcomes. Primary outcome was parasitological failure by day 28.

results1433 pregnant women were screened, of whom 272 met entry criteria and were randomised; 28 to SP, 81 to CD, 80 to SP+AQ and 83 to AQ+AS. Follow-up to day 28 post treatment was 251/272 (92%), and to 6 weeks following delivery 91%. By day 28 parasitological failure rates were 4/26 (15%, 95%CI 4-35) in the SP, 18/77 (23%, 95%CI 14-34) in the CD, 1/73 (1% 95%CI 7-0.001) in the SP+AQ and 7/75 (9% 95%CI 4-18) in the AQ+AS arms respectively. After correction by molecular markers for reinfection the parasitological failure rates at day 28 were 18% for CD, 1% for SP+AQ and 4.5% for AQ+AS. There were two maternal deaths during the trial. There was no apparent excess of stillbirths or adverse birth outcomes in any arm. Parasitological responses were strikingly better in pregnant women than in children treated with the same drugs at this site.

conclusionsFailure rates with monotherapy were unacceptably high. The two combinations tested were efficacious and appeared safe. It should not be assumed that efficacy in pregnancy is the same as in children.

trial registrationClinicalTrials.gov NCT00146731.

Indexed as

AdultAmodiaquineArtemisininsArtesunateDapsoneDrug CombinationsDrug Therapy, CombinationFemaleHumansMalariaPregnancyPregnancy Complications, ParasiticProguanilPyrimethamineSulfadoxineTanzaniaAmodiaquineArtemisininsArtesunatechloroguanil, dapsone drug combinationDapsoneDrug Combinationsfanasil, pyrimethamine drug combinationProguanilPyrimethamineSulfadoxine

Identifiers

PMID19352498
PMCPMC2662423
OpenAlexW1986113463

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.