Evidence map›Paper›PMID 25701866›Full record

Trial reportThe Journal of infectious diseases2015

A Randomized Trial to Compare the Safety, Tolerability, and Effectiveness of 3 Antimalarial Regimens for the Prevention of Malaria in Nigerian Patients With Sickle Cell Disease.

Rasaq Olaosebikan, Kolade Ernest, Kalifa Bojang, Olugbenga Mokuolu, Andrea M Rehman, Muna Affara, Davis Nwakanma, Jean-René Kiechel, Taofik Ogunkunle, Tope Olagunju and 9 more

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of infectious diseases, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01319448 (Safety and Tolerability of Bi-monthly Intermittent Preventive Treatment With Mefloquine-Artesunate or Sulfadoxine-Pyrimethamine Plus Amodiaquine for Prevention of Malaria and Related Complications in Patients With Sickle Cell Anaemia.), which is not on this map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 pooled it
0.9field-weighted citation impact, top 26% 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.

NCT01319448 phase1 / phase2completednot on this map

Safety and Tolerability of Bi-monthly Intermittent Preventive Treatment With Mefloquine-Artesunate or Sulfadoxine-Pyrimethamine Plus Amodiaquine for Prevention of Malaria and Related Complications in Patients With Sickle Cell Anaemia.

TypeinterventionalSponsorLondon School of Hygiene and Tropical MedicineRan2011 to 2013Enrolled270ConditionsMalaria, Sickle Cell CrisisArmsProguanil, mefloquine plus artesunate, Sulfadoxine-pyrimethamine plus amodiaquine
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 2 syntheses or guidelines pooled it, 18 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Article
  5. Review
  6. Article
  7. Article
  8. Sickle Cell Disease Clinical Trials and Phenotypes.Journal of tropical diseases & public health · 2018
    Article
  9. Review
  10. Sickle cell disease.BMJ clinical evidence · 2016
    Review
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

19 authors at 4 institutions in 4 countries.

Rasaq OlaosebikanUniversity of Ilorin Teaching Hospital, Nigeria Medical Research Council Unit, Banjul, Gambia University of Nebraska Medical Centre, Omaha.
Kolade ErnestUniversity of Ilorin Teaching Hospital, Nigeria.
Kalifa BojangMedical Research Council Unit, Banjul, Gambia.
Olugbenga MokuoluUniversity of Ilorin Teaching Hospital, Nigeria.
Andrea M RehmanLondon School of Hygiene and Tropical Medicine, United Kingdom.
Muna AffaraMedical Research Council Unit, Banjul, Gambia.
Davis NwakanmaMedical Research Council Unit, Banjul, Gambia.
Jean-René KiechelDrugs for Neglected Diseases Initiative, Geneva, Switzerland.
Taofik OgunkunleUniversity of Ilorin Teaching Hospital, Nigeria.
Tope OlagunjuUniversity of Ilorin Teaching Hospital, Nigeria.
Rukayat MurtalaUniversity of Ilorin Teaching Hospital, Nigeria.
Peter OmefeUniversity of Ilorin Teaching Hospital, Nigeria.
Tosin LambeUniversity of Ilorin Teaching Hospital, Nigeria.
Surajudeen BelloUniversity of Ilorin Teaching Hospital, Nigeria.
Olayinka IbrahimUniversity of Ilorin Teaching Hospital, Nigeria.
Benedict OlorunsolaUniversity of Ilorin Teaching Hospital, Nigeria.
Ayotade OjuawoUniversity of Ilorin Teaching Hospital, Nigeria.
Brian GreenwoodLondon School of Hygiene and Tropical Medicine, United Kingdom.
Paul MilliganLondon School of Hygiene and Tropical Medicine, United Kingdom.
University of Ilorin Teaching Hospital · NGLondon School of Hygiene & Tropical Medicine · GBMRC Unit the Gambia · GMDrugs for Neglected Diseases Initiative · CH

Funding

Medical Research Council MC_UP_A900_1117Medical Research Council MC_UP_A900_1118Medical Research Council MR/K012126/1Wellcome TrustWellcome Trust 086153/Z/08/Z
6 · The paper itself

Abstract

backgroundMalaria prophylaxis is recommended for persons with sickle cell disease (SCD), but the value of this has been questioned. The aim of this study was to find out whether intermittent preventive treatment (IPT) with a fixed-dose combination of mefloquine-artesunate (MQAS) or sulfadoxine-pyrimethamine plus amodiaquine (SPAQ) was more effective than daily proguanil for malaria prevention in subjects with SCD.

methodsPatients with SCD were randomized to receive daily treatment with proguanil or IPT with either MQAS or SPAQ once every 2 months at routine clinic visits. Patients were followed up for 14 months.

findingsA total of 270 patients with SCD were studied, with 90 in each group. Adherence to the IPT regimens was excellent, but 57% of patients took <75% of their daily doses of proguanil. IPT was well tolerated; the most common side effects were vomiting and abdominal pain. Protective efficacy against malaria, compared with daily proguanil, was 61% (95% confidence interval, 3%-84%) for MQAS and 36% (40%-70%) for SPAQ. There were fewer outpatient illness episodes in children who received IPT than those who received proguanil.

conclusionsIPT with MQAS administered to patients with SCD during routine clinic visits was well tolerated and more effective in preventing malaria than daily prophylaxis with proguanil. CLINICAL TRIALS REGISTRATION: NCT01319448 and ISRCTN46158146.

Indexed as

AdolescentAdultAnemia, Sickle CellAntimalarialsChildChild, PreschoolFemaleHumansMalariaMaleMedication AdherenceNigeriaYoung AdultAntimalarialschemopreventionintermittent preventive treatmentmalariamefloquine-artesunateproguanilprophylaxissickle cell disease

Identifiers

PMID25701866
PMCPMC4512609
OpenAlexW2115876732

What OpenQuestion holds

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LicenceCC BY
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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.