Comparison of intermittent screening (using ultra-sensitive malaria rapid diagnostic test) and treatment (using a newly registered antimalarial pyronaridine-artesunate—PYRAMAX®) to standard intermittent preventive treatment with sulfadoxine-pyrimethamine for the prevention of malaria in pregnant women living in endemic areas: ULTRAPYRAPREG

Maketa, Vivi; Kabalu, Japhet; Kabena, Melissa; Luzolo, Flory K.; Mavoko, Hypolite Muhindo; Schallig, Henk D. F. H.; Kayentao, Kassoum; Mens, Pètra F.; Lutumba, Pascal; Tinto, Halidou

doi:10.1186/s13063-022-06884-8

Cited by 3 publications

(3 citation statements)

References 18 publications

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“…This study was part of the ULTRAPYRAPREG project [ 24 ] ( https://clinicaltrials.gov/study/NCT04783051 ). ULTRAPYRAPREG is a clinical trial that aims to assess whether intermittent screening with uRDT and treatment using pyronaridine-artesunate (IST-US-PA) is non inferior compared to the classic intermittent preventive treatment (using sulfadoxine-pyrimethamine, IPTp-SP) in terms of the proportion of maternal malaria, maternal anaemia, spontaneous abortions or intrauterine death during pregnancy, fetal morbidity and neonatal mortality at childbirth.…”

Section: Methodsmentioning

confidence: 99%

Performance of ultra-sensitive malaria rapid diagnostic test to detect Plasmodium falciparum infection in pregnant women in Kinshasa, the Democratic Republic of the Congo

Kabalu Tshiongo,

Luzolo,

Kabena

et al. 2023

Malar J

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Background Low peripheral parasitaemia caused by sequestration of Plasmodium falciparum in the placenta hampers the diagnosis of malaria in pregnant women, leading to microscopy or conventional rapid diagnostic tests (RDTs) false-negative results. Although mainly asymptomatic, maternal malaria remains harmful to pregnant women and their offspring in endemic settings and must be adequately diagnosed. Ultra-sensitive RDTs (uRDTs) are thought to be more sensitive than RDTs, and their diagnostic performance was assessed in the current study in pregnant women living in Kinshasa, a stable malaria transmission area in the Democratic Republic of the Congo. Methods To assess and compare the diagnostic performances of both RDTs and uRDTs, 497 peripheral blood samples were tested using microscopy and quantitative polymerase chain reaction (qPCR) as the index and the reference tests, respectively. The agreement between the different diagnostic tests assessed was estimated by Cohen's Kappa test. Results The median parasite density by qPCR was 292 p/μL of blood [IQR (49.7–1137)]. Using qPCR as the reference diagnostic test, the sensitivities of microscopy, RDT and uRDT were respectively [55.7% (95% CI 47.6–63.6)], [81.7% (95%CI 74.7–87.3)] and [88% (95% CI 81.9–92.6)]. The specificities of the tests were calculated at 98.5% (95% CI 96.6–99.5), 95.2% (95% CI 92.5–97.2) and 94.4% (95% CI 91.4–96.6) for microscopy, RDT and uRDT, respectively. The agreement between qPCR and uRDT was almost perfect (Kappa = 0.82). For parasite density (qPCR) below 100 p/µL, the sensitivity of RDT was 62% (95% CI 47.1–75.3) compared to 68% (95% CI 53.3–80.4) for uRDT. Between 100 and 200 p/µL, the sensitivity of RDT was higher, but still lower compared to uRDT: 89.4% (95% CI 66.8–98.7) for RDT versus 100% (95% CI 82.3–100) for uRDT. In both cases, microscopy was lower, with 20% (95% CI 10–33.7) and 47.3% (95% CI 24.4–71.1) respectively. Conclusions uRDT has the potential to improve malaria management in pregnant women as it has been found to be slightly more sensitive than RDT in the detection of malaria in pregnant women but the difference was not significant. Microscopy has a more limited value for the diagnosis of malaria during the pregnancy, because of its lower sensitivity.

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Section: Methodsmentioning

confidence: 99%

Performance of ultra-sensitive malaria rapid diagnostic test to detect Plasmodium falciparum infection in pregnant women in Kinshasa, the Democratic Republic of the Congo

Kabalu Tshiongo,

Luzolo,

Kabena

et al. 2023

Malar J

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“…Because PYR and PQP both have long half-lives and exhibit different mechanisms of action, their use in combination may reduce the risk for drug resistance selection and spread. 15,16 As regard to the potential use in pregnant women, neither drug has shown any teratogenic liabilities, 17,18 with PYR-AS being investigated in this population, 19 and DHA-PQP characterized in IPTp. 13,14 Malaria chemoprevention is deployed to protect infants, children, and pregnant women without clinical malaria, and pharmacological agents must have a low safety risk and favorable tolerability profile.…”

Section: How Might This Change Clinical Pharmacology or Translational...mentioning

confidence: 99%

“…Because PYR and PQP both have long half‐lives and exhibit different mechanisms of action, their use in combination may reduce the risk for drug resistance selection and spread. 15 , 16 As regard to the potential use in pregnant women, neither drug has shown any teratogenic liabilities, 17 , 18 with PYR‐AS being investigated in this population, 19 and DHA‐PQP characterized in IPTp. 13 , 14 …”

Section: Introductionmentioning

confidence: 99%

Randomized, placebo‐controlled, double‐blind phase I trial of co‐administered pyronaridine and piperaquine in healthy adults of sub‐Saharan origin

Kuemmerle,

Gossen,

Janin

et al. 2024

Clinical Translational Sci

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Drug resistance to sulfadoxine‐pyrimethamine and amodiaquine threatens the efficacy of malaria chemoprevention interventions in children and pregnant women. Combining pyronaridine (PYR) and piperaquine (PQP), both components of approved antimalarial therapies, has the potential to protect vulnerable populations from severe malaria. This randomized, double‐blind, placebo‐controlled (double‐dummy), parallel‐group, single site phase I study in healthy adult males or females of Black sub‐Saharan African ancestry investigated the safety, tolerability, and pharmacokinetics of PYR + PQP (n = 15), PYR + placebo (n = 8), PQP + placebo (n = 8), and double placebo (n = 6) administered orally once daily for 3 days at the registered dose for the treatment of uncomplicated malaria. All participants completed the study. Forty‐five adverse events were reported in 26 participants, most (41/45) were mild/moderate in severity, with no serious adverse events, deaths, or study withdrawals. Adverse events were reported in 66.7% (10/15) of participants administered PYR + PQP, 87.5% (7/8) with PYR + placebo, 50.0% (4/8) with PQP + placebo, and 83.3% (5/6) with placebo. For PYR containing regimens, five of 23 participants had asymptomatic transient increases in alanine and/or aspartate aminotransferase. With PQP containing regimens, four of 23 participants had mild Fridericia‐corrected QT interval prolongation. Liver enzyme elevations and prolonged QTc interval were consistent with observations for PYR‐artesunate and dihydroartemisinin‐PQP, respectively, administered to healthy adults and malaria patients. Increases in PYR and PQP exposures were observed following co‐administration versus placebo, with substantial interparticipant variability. The findings suggest that PYR + PQP may have potential in chemoprevention strategies. Further studies are needed in the target populations to assess chemoprotective efficacy and define the benefit–risk profile, with special considerations regarding hepatic and cardiac safety.

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Performance of rapid diagnostic test, light microscopy, and polymerase chain reaction in pregnant women with asymptomatic malaria in Nigeria

Adebusuyi,

Olorunfemi,

Fagbemi

et al. 2024

IJID Regions

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Cited by 3 publications

References 18 publications

Performance of ultra-sensitive malaria rapid diagnostic test to detect Plasmodium falciparum infection in pregnant women in Kinshasa, the Democratic Republic of the Congo

Performance of ultra-sensitive malaria rapid diagnostic test to detect Plasmodium falciparum infection in pregnant women in Kinshasa, the Democratic Republic of the Congo

Randomized, placebo‐controlled, double‐blind phase I trial of co‐administered pyronaridine and piperaquine in healthy adults of sub‐Saharan origin

Performance of rapid diagnostic test, light microscopy, and polymerase chain reaction in pregnant women with asymptomatic malaria in Nigeria

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