Evidence map›Paper›PMID 26889763›Full record

ArticleBritish journal of clinical pharmacology2016

Safety, tolerability and pharmacokinetic properties of coadministered azithromycin and piperaquine in pregnant Papua New Guinean women.

Brioni R Moore, John M Benjamin, Siu On Auyeung, Sam Salman, Gumul Yadi, Suzanne Griffin, Madhu Page-Sharp, Kevin T Batty, Peter M Siba, Ivo Mueller and 2 more

Open access · bronzeAbstract read
In one paragraph

Article in British journal of clinical pharmacology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
2.1field-weighted citation impact, top 12% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 25 citations in OpenAlex.

  1. Trial
  2. Piperaquine-Induced QTc Prolongation Decreases With Repeated Monthly Dihydroartemisinin-Piperaquine Dosing in Pregnant Ugandan Women.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022
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  8. Review
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  15. Observational
  16. Azithromycin for Malaria?The American journal of tropical medicine and hygiene · 2016
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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

12 authors at 5 institutions in 3 countries.

Brioni R MooreSchool of Medicine and Pharmacology, The University of Western Australia, Crawley, Western Australia, Australia.
John M BenjaminPapua New Guinea Institute of Medical Research, Madang, Madang Province, Papua New Guinea.
Siu On AuyeungSchool of Medicine and Pharmacology, The University of Western Australia, Crawley, Western Australia, Australia.
Sam SalmanSchool of Medicine and Pharmacology, The University of Western Australia, Crawley, Western Australia, Australia.
Gumul YadiPapua New Guinea Institute of Medical Research, Madang, Madang Province, Papua New Guinea.
Suzanne GriffinPapua New Guinea Institute of Medical Research, Madang, Madang Province, Papua New Guinea.
Madhu Page-SharpSchool of Pharmacy, Curtin University of Technology, Bentley, Western Australia, Australia.
Kevin T BattySchool of Pharmacy, Curtin University of Technology, Bentley, Western Australia, Australia.
Peter M SibaPapua New Guinea Institute of Medical Research, Madang, Madang Province, Papua New Guinea.
Ivo MuellerInfection and Immunity, Walter and Eliza Hall Institute, Melbourne, Victoria, Australia.
Stephen J RogersonDepartment of Medicine (RMH), The University of Melbourne, Parkville, Victoria, Australia.
Timothy Me DavisSchool of Medicine and Pharmacology, The University of Western Australia, Crawley, Western Australia, Australia.
Papua New Guinea Institute of Medical Research · PGUniversity of Western Australia · AUCurtin University · AUBarcelona Institute for Global Health · ESUniversity of Melbourne · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsThe aim of the present study was to investigate the safety, tolerability and pharmacokinetics of coadministered azithromycin (AZI) and piperaquine (PQ) for treating malaria in pregnant Papua New Guinean women.

methodsThirty pregnant women (median age 22 years; 16-32 weeks' gestation) were given three daily doses of 1 g AZI plus 960 mg PQ tetraphosphate with detailed monitoring/blood sampling over 42 days. Plasma AZI and PQ were assayed using liquid chromatography-mass spectrometry and high-performance liquid chromatography, respectively. Pharmacokinetic analysis was by population-based compartmental models.

resultsThe treatment was well tolerated. The median (interquartile range) increase in the rate-corrected electrocardiographic QT interval 4 h postdose [12 (6-26) ms(0) (.5) ] was similar to that found in previous studies of AZI given in pregnancy with other partner drugs. Six women with asymptomatic malaria cleared their parasitaemias within 72 h. Two apararasitaemic women developed late uncomplicated Plasmodium falciparum infections on Days 42 and 83. Compared with previous pregnancy studies, the area under the concentration-time curve (AUC0-∞ ) for PQ [38818 (24354-52299) μg h l(-1) ] was similar to published values but there was a 52% increase in relative bioavailability with each dose. The AUC0-∞ for AZI [46799 (43526-49462) μg h l(-1) ] was at least as high as reported for higher-dose regimens, suggesting saturable absorption and/or concentration-dependent tissue uptake and clearance from the central compartment.

conclusionsAZI-PQ appears to be well tolerated and safe in pregnancy. Based on the present/other data, total AZI doses higher than 3 g for the treatment and prevention of malaria may be unnecessary in pregnant women, while clearance of parasitaemia could improve the relative bioavailability of PQ.

Indexed as

AdolescentAdultAntimalarialsArea Under CurveAzithromycinBiological AvailabilityChromatography, High Pressure LiquidChromatography, LiquidDrug Therapy, CombinationFemaleHumansMalaria, FalciparumMass SpectrometryModels, BiologicalPapua New GuineaPiperazinesAntimalarialsAzithromycinpiperaquinePiperazinesQuinolinesazithromycinmalariapharmacokineticspiperaquinepregnancysafety

Identifiers

PMID26889763
PMCPMC4917786
OpenAlexW2286507655

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.