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Article ; Online: Development of New Strategies for Malaria Chemoprophylaxis: From Monoclonal Antibodies to Long-Acting Injectable Drugs.

Moehrle, Joerg J

Tropical medicine and infectious disease

2022 Volume 7, Issue 4

Abstract: Drug discovery for malaria has traditionally focused on orally available drugs that kill the abundant, parasitic blood stage. Recently, there has also been an interest in injectable medicines, in the form of monoclonal antibodies (mAbs) with long-lasting ...

Abstract	Drug discovery for malaria has traditionally focused on orally available drugs that kill the abundant, parasitic blood stage. Recently, there has also been an interest in injectable medicines, in the form of monoclonal antibodies (mAbs) with long-lasting plasma half-lives or long-lasting depot formulations of small molecules. These could act as prophylactic drugs, targeting the sporozoites and other earlier parasitic stages in the liver, when the parasites are less numerous, or as another intervention strategy targeting the formation of infectious gametocytes. Generally speaking, the development of mAbs is less risky (costly) than small-molecule drugs, and they have an excellent safety profile with few or no off-target effects. Therefore, populations who are the most vulnerable to malaria, i.e., pregnant women and young children would have access to such new treatments much faster than is presently the case for new antimalarials. An analysis of mAbs that were successfully developed for oncology illustrates some of the feasibility aspects, and their potential as affordable drugs in low- and middle-income countries.
Language	English
Publishing date	2022-04-07
Publishing country	Switzerland
Document type	Journal Article ; Review
ISSN	2414-6366
ISSN (online)	2414-6366
DOI	10.3390/tropicalmed7040058
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Article ; Online: Towards the next generation of antimalaria combination therapies.

Möhrle, Jörg J

The Lancet. Infectious diseases

2021 Volume 21, Issue 12, Page(s) 1620–1621

MeSH term(s)	Antimalarials/therapeutic use ; Combined Modality Therapy ; Humans
Chemical Substances	Antimalarials
Language	English
Publishing date	2021-10-26
Publishing country	United States
Document type	Journal Article ; Comment
ZDB-ID	2061641-7
ISSN	1474-4457 ; 1473-3099
ISSN (online)	1474-4457
ISSN	1473-3099
DOI	10.1016/S1473-3099(21)00270-X
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Article ; Online: Moving seasonal malaria chemoprevention out of its geographical isolation.

Olotu, Ally / Möhrle, Jörg J

The Lancet. Infectious diseases

2023 Volume 23, Issue 10, Page(s) 1102–1103

MeSH term(s)	Humans ; Infant ; Seasons ; Malaria/prevention & control ; Malaria/drug therapy ; Antimalarials/therapeutic use ; Chemoprevention
Chemical Substances	Antimalarials
Language	English
Publishing date	2023-07-03
Publishing country	United States
Document type	Journal Article ; Comment
ZDB-ID	2061641-7
ISSN	1474-4457 ; 1473-3099
ISSN (online)	1474-4457
ISSN	1473-3099
DOI	10.1016/S1473-3099(23)00268-2
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Article: Using Cryopreserved

Jiménez-Díaz, María-Belén / Möhrle, Jörg J / Angulo-Barturen, Iñigo / Demarta-Gatsi, Claudia

Microorganisms

2023 Volume 11, Issue 9

Abstract: In addition to vector control, long-lasting insecticidal nets and case management, the prevention of infection through vaccination and/or chemoprevention are playing an increasing role in the drive to eradicate malaria. These preventative approaches ... ...

Abstract	In addition to vector control, long-lasting insecticidal nets and case management, the prevention of infection through vaccination and/or chemoprevention are playing an increasing role in the drive to eradicate malaria. These preventative approaches represent opportunities for improvement: new drugs may be discovered that target the early infectious stages of the
Language	English
Publishing date	2023-08-31
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2720891-6
ISSN	2076-2607
ISSN	2076-2607
DOI	10.3390/microorganisms11092209
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Article ; Online: Model-informed target product profiles of long-acting-injectables for use as seasonal malaria prevention.

Burgert, Lydia / Reiker, Theresa / Golumbeanu, Monica / Möhrle, Jörg J / Penny, Melissa A

PLOS global public health

2022 Volume 2, Issue 3, Page(s) e0000211

Abstract: Seasonal malaria chemoprevention (SMC) has proven highly efficacious in reducing malaria incidence. However, the continued success of SMC is threatened by the spread of resistance against one of its main preventive ingredients, Sulfadoxine-Pyrimethamine ( ...

Abstract	Seasonal malaria chemoprevention (SMC) has proven highly efficacious in reducing malaria incidence. However, the continued success of SMC is threatened by the spread of resistance against one of its main preventive ingredients, Sulfadoxine-Pyrimethamine (SP), operational challenges in delivery, and incomplete adherence to the regimens. Via a simulation study with an individual-based model of malaria dynamics, we provide quantitative evidence to assess long-acting injectables (LAIs) as potential alternatives to SMC. We explored the predicted impact of a range of novel preventive LAIs as a seasonal prevention tool in children aged three months to five years old during late-stage clinical trials and at implementation. LAIs were co-administered with a blood-stage clearing drug once at the beginning of the transmission season. We found the establishment of non-inferiority of LAIs to standard 3 or 4 rounds of SMC with SP-amodiaquine was challenging in clinical trial stages due to high intervention deployment coverage. However, our analysis of implementation settings where the achievable SMC coverage was much lower, show LAIs with fewer visits per season are potential suitable replacements to SMC. Suitability as a replacement with higher impact is possible if the duration of protection of LAIs covered the duration of the transmission season. Furthermore, optimising LAIs coverage and protective efficacy half-life via simulation analysis in settings with an SMC coverage of 60% revealed important trade-offs between protective efficacy decay and deployment coverage. Our analysis additionally highlights that for seasonal deployment for LAIs, it will be necessary to investigate the protective efficacy decay as early as possible during clinical development to ensure a well-informed candidate selection process.
Language	English
Publishing date	2022-03-14
Publishing country	United States
Document type	Journal Article
ISSN	2767-3375
ISSN (online)	2767-3375
DOI	10.1371/journal.pgph.0000211
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Article ; Online: Treating malaria: new drugs for a new era.

Shanks, G Dennis / Möhrle, Jörg J

The Lancet. Infectious diseases

2017 Volume 17, Issue 12, Page(s) 1223–1224

MeSH term(s)	Antimalarials ; Humans ; Malaria
Chemical Substances	Antimalarials
Language	English
Publishing date	2017-09-12
Publishing country	United States
Document type	Journal Article ; Comment
ZDB-ID	2061641-7
ISSN	1474-4457 ; 1473-3099
ISSN (online)	1474-4457
ISSN	1473-3099
DOI	10.1016/S1473-3099(17)30475-9
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Conference proceedings: Introduction to Medicines for Malaria Venture (MMV)

Möhrle, Jörg J.

2014 , Page(s) 13mal10

Event/congress	11th Malaria Meeting; Aachen; ; German Society for Parasitology (DGP e.V.); 2013
Keywords	Medizin, Gesundheit
Publishing date	2014-01-29
Publisher	German Medical Science GMS Publishing House; Düsseldorf
Document type	Conference proceedings
DOI	10.3205/13mal10
Database	German Medical Science

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Article ; Online: Haematological response in experimental human Plasmodium falciparum and Plasmodium vivax malaria.

Woolley, Stephen D / Marquart, Louise / Woodford, John / Chalon, Stephan / Moehrle, Joerg J / McCarthy, James S / Barber, Bridget E

Malaria journal

2021 Volume 20, Issue 1, Page(s) 470

Abstract: Background: Malaria-associated anaemia, arising from symptomatic, asymptomatic and submicroscopic infections, is a significant cause of morbidity worldwide. Induced blood stage malaria volunteer infection studies (IBSM-VIS) provide a unique opportunity ... ...

Abstract	Background: Malaria-associated anaemia, arising from symptomatic, asymptomatic and submicroscopic infections, is a significant cause of morbidity worldwide. Induced blood stage malaria volunteer infection studies (IBSM-VIS) provide a unique opportunity to evaluate the haematological response to early Plasmodium falciparum and Plasmodium vivax infection. Methods: This study was an analysis of the haemoglobin, red cell counts, and parasitaemia data from 315 participants enrolled in IBSM-VIS between 2012 and 2019, including 269 participants inoculated with the 3D7 strain of P. falciparum (Pf3D7), 15 with an artemisinin-resistant P. falciparum strain (PfK13) and 46 with P. vivax. Factors associated with the fractional fall in haemoglobin (Hb-FF) were evaluated, and the malaria-attributable erythrocyte loss after accounting for phlebotomy-related losses was estimated. The relative contribution of parasitized erythrocytes to the malaria-attributable erythrocyte loss was also estimated. Results: The median peak parasitaemia prior to treatment was 10,277 parasites/ml (IQR 3566-27,815), 71,427 parasites/ml [IQR 33,236-180,213], and 34,840 parasites/ml (IQR 13,302-77,064) in participants inoculated with Pf3D7, PfK13, and P. vivax, respectively. The median Hb-FF was 10.3% (IQR 7.8-13.3), 14.8% (IQR 11.8-15.9) and 11.7% (IQR 8.9-14.5) in those inoculated with Pf3D7, PfK13 and P. vivax, respectively, with the haemoglobin nadir occurring a median 12 (IQR 5-21), 15 (IQR 7-22), and 8 (IQR 7-15) days following inoculation. In participants inoculated with P. falciparum, recrudescence was associated with a greater Hb-FF, while in those with P. vivax, the Hb-FF was associated with a higher pre-treatment parasitaemia and later day of anti-malarial treatment. After accounting for phlebotomy-related blood losses, the estimated Hb-FF was 4.1% (IQR 3.1-5.3), 7.2% (IQR 5.8-7.8), and 4.9% (IQR 3.7-6.1) in participants inoculated with Pf3D7, PfK13, and P. vivax, respectively. Parasitized erythrocytes were estimated to account for 0.015% (IQR 0.006-0.06), 0.128% (IQR 0.068-0.616) and 0.022% (IQR 0.008-0.082) of the malaria-attributable erythrocyte loss in participants inoculated with Pf3D7, PfK13, and P. vivax, respectively. Conclusion: Early experimental P. falciparum and P. vivax infection resulted in a small but significant fall in haemoglobin despite parasitaemia only just at the level of microscopic detection. Loss of parasitized erythrocytes accounted for < 0.2% of the total malaria-attributable haemoglobin loss.
MeSH term(s)	Adult ; Anemia/drug therapy ; Anemia/parasitology ; Antimalarials/therapeutic use ; Erythrocytes/parasitology ; Female ; Humans ; Malaria, Falciparum/complications ; Malaria, Falciparum/drug therapy ; Malaria, Falciparum/parasitology ; Malaria, Vivax/complications ; Malaria, Vivax/drug therapy ; Malaria, Vivax/parasitology ; Male ; Middle Aged ; Parasitemia/drug therapy ; Parasitemia/parasitology ; Plasmodium falciparum/drug effects ; Plasmodium vivax/drug effects ; Young Adult
Chemical Substances	Antimalarials
Language	English
Publishing date	2021-12-20
Publishing country	England
Document type	Journal Article
ISSN	1475-2875
ISSN (online)	1475-2875
DOI	10.1186/s12936-021-04003-7
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Article ; Online: PCR correction strategies for malaria drug trials: updates and clarifications.

Felger, Ingrid / Snounou, Georges / Hastings, Ian / Moehrle, Joerg J / Beck, Hans-Peter

The Lancet. Infectious diseases

2019 Volume 20, Issue 1, Page(s) e20–e25

Abstract: Malaria drug trials conducted in endemic areas face a major challenge in their analysis because it is difficult to establish whether parasitaemia in blood samples collected after treatment indicate drug failure or a new infection acquired after treatment. ...

Abstract	Malaria drug trials conducted in endemic areas face a major challenge in their analysis because it is difficult to establish whether parasitaemia in blood samples collected after treatment indicate drug failure or a new infection acquired after treatment. It is therefore vital to reliably distinguish drug failures from new infections in order to obtain accurate estimates of drug failure rates. This distinction can be achieved for Plasmodium falciparum by comparing parasite genotypes obtained at the time of treatment (the baseline) and on the day of recurring parasitaemia. Such PCR correction is required to obtain accurate failure rates, even for new effective drugs. Despite the routine use of PCR correction in surveillance of drug resistance and in clinical drug trials, limitations inherent to the molecular genotyping methods have led some researchers to question the validity of current PCR correction strategies. Here we describe and discuss recent developments in these genotyping approaches, with a particular focus on method validation and limitations of the genotyping strategies. Our aim is to update scientists from public and private bodies who are working on the development, deployment, and surveillance of new malaria drugs. We aim to promote discussion around these issues and argue for the adoption of improved standardised PCR correction methodologies.
MeSH term(s)	Antimalarials/therapeutic use ; Clinical Trials as Topic ; Genotype ; Genotyping Techniques/methods ; Humans ; Malaria, Falciparum/diagnosis ; Malaria, Falciparum/drug therapy ; Plasmodium falciparum/classification ; Plasmodium falciparum/genetics ; Plasmodium falciparum/isolation & purification ; Polymerase Chain Reaction/methods ; Recurrence ; Treatment Outcome
Chemical Substances	Antimalarials
Language	English
Publishing date	2019-09-17
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	2061641-7
ISSN	1474-4457 ; 1473-3099
ISSN (online)	1474-4457
ISSN	1473-3099
DOI	10.1016/S1473-3099(19)30426-8
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Article ; Online: Characterizing the Blood-Stage Antimalarial Activity of Tafenoquine in Healthy Volunteers Experimentally Infected With Plasmodium falciparum.

Barber, Bridget E / Abd-Rahman, Azrin N / Webster, Rebecca / Potter, Adam J / Llewellyn, Stacey / Marquart, Louise / Sahai, Nischal / Leelasena, Indika / Birrell, Geoffrey W / Edstein, Michael D / Shanks, G Dennis / Wesche, David / Moehrle, Joerg J / McCarthy, James S

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

2023 Volume 76, Issue 11, Page(s) 1919–1927

Abstract: Background: The long-acting 8-aminoquinoline tafenoquine may be a good candidate for mass drug administration if it exhibits sufficient blood-stage antimalarial activity at doses low enough to be tolerated by glucose 6-phosphate dehydrogenase (G6PD)- ... ...

Abstract	Background: The long-acting 8-aminoquinoline tafenoquine may be a good candidate for mass drug administration if it exhibits sufficient blood-stage antimalarial activity at doses low enough to be tolerated by glucose 6-phosphate dehydrogenase (G6PD)-deficient individuals. Methods: Healthy adults with normal levels of G6PD were inoculated with Plasmodium falciparum 3D7-infected erythrocytes on day 0. Different single oral doses of tafenoquine were administered on day 8. Parasitemia and concentrations of tafenoquine and the 5,6-orthoquinone metabolite in plasma/whole blood/urine were measured and standard safety assessments performed. Curative artemether-lumefantrine therapy was administered if parasite regrowth occurred, or on day 48 ± 2. Outcomes were parasite clearance kinetics, pharmacokinetic and pharmacokinetic/pharmacodynamic (PK/PD) parameters from modelling, and dose simulations in a theoretical endemic population. Results: Twelve participants were inoculated and administered 200 mg (n = 3), 300 mg (n = 4), 400 mg (n = 2), or 600 mg (n = 3) tafenoquine. The parasite clearance half-life with 400 mg or 600 mg (5.4 hours and 4.2 hours, respectively) was faster than with 200 mg or 300 mg (11.8 hours and 9.6 hours, respectively). Parasite regrowth occurred after dosing with 200 mg (3/3 participants) and 300 mg (3/4 participants) but not after 400 mg or 600 mg. Simulations using the PK/PD model predicted that 460 mg and 540 mg would clear parasitaemia by a factor of 106 and 109, respectively, in a 60-kg adult. Conclusions: Although a single dose of tafenoquine exhibits potent P. falciparum blood-stage antimalarial activity, the estimated doses to effectively clear asexual parasitemia will require prior screening to exclude G6PD deficiency. Clinical Trials Registration. Australian and New Zealand Clinical Trials Registry (ACTRN12620000995976).
MeSH term(s)	Adult ; Humans ; Antimalarials/adverse effects ; Plasmodium falciparum ; Healthy Volunteers ; Parasitemia/drug therapy ; Artemether/pharmacology ; Artemether/therapeutic use ; Artemether, Lumefantrine Drug Combination/therapeutic use ; Australia ; Malaria, Falciparum/drug therapy ; Malaria, Falciparum/parasitology
Chemical Substances	Antimalarials ; tafenoquine (262P8GS9L9) ; Artemether (C7D6T3H22J) ; Artemether, Lumefantrine Drug Combination
Language	English
Publishing date	2023-02-06
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1099781-7
ISSN	1537-6591 ; 1058-4838
ISSN (online)	1537-6591
ISSN	1058-4838
DOI	10.1093/cid/ciad075
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