Ferroquine and artesunate in African adults and children with Plasmodium falciparum malaria: A phase 2, multicentre, randomised, double-blind, dose-ranging, non-inferiority study

The Lancet Infectious Diseases

Volumn 15, Issue 12, 2015, Pages 1409-1419

  Held, Jana ^a,b,c   Supan, Christian ^b   Salazar, Carmen L O ^b   Tinto, Halidou ^d   Bonkian, Léa N ^d   Nahum, Alain ^e   Moulero, Bancole ^e   Sié, Ali ^f   Coulibaly, Boubacar ^f   Sirima, Sodiomon B ^g,h   Siribie, Mohamadou ^g   Otsyula, Nekoye ⁱ   Otieno, Lucas ⁱ   Abdallah, Ahmed M ^j   Kimutai, Robert ^j   Bouyou Akotet, Marielle ^k   Kombila, Maryvonne ^k   Koiwai, Kimiko ^l   Cantalloube, Cathy ^l   Din Bell, Chantal ^l   Djeriou, Elhadj ^l   Waitumbi, John ⁱ   Mordmüller, Benjamin ^a,b,c   Ter Minassian, Daniel ^b   Lell, Bertrand ^a,b,c   Kremsner, Peter G ^a,b,c   more..

^a UNIVERSITY HOSPITAL TÜBINGEN   (Germany)

^b Centre de Recherches Médicales de Lambaréné HÔpital Albert Schweitzer   (Gabon)

^c LEIBNIZ INSTITUTE FOR EXPERIMENTAL VIROLOGY   (Germany)

^d CENTRE MURAZ   (Burkina Faso)

^e CENTRE DE RECHERCHE ENTOMOLOGIQUE DE COTONOU CREC   (Benin)

^f CENTRE DE RECHERCHE EN SANTÉ DE NOUNA   (Burkina Faso)

^g Groupe de Recherche Action en Sante   (Burkina Faso)

^h Burkina Faso   (Burkina Faso)

ⁱ KENYA MEDICAL RESEARCH INSTITUTE   (Kenya)

^j KEMRI WELLCOME TRUST RESEARCH PROGRAMME   (Kenya)

^k UNIVERSITÉ DES SCIENCES DE LA SANTÉ   (Gabon)

^l SANOFI   (France)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ARTESUNATE; FERROQUINE; AMINOQUINOLINE DERIVATIVE; ANTIMALARIAL AGENT; ARTEMISININ DERIVATIVE; FERROUS ION;

ABDOMINAL PAIN; ADOLESCENT; ADULT; AFRICAN; AREA UNDER THE CURVE; ARTICLE; BODY TEMPERATURE; BODY WEIGHT; BRONCHITIS; CHILD; COUGHING; DISEASE COURSE; DOUBLE BLIND PROCEDURE; DRUG DOSE REGIMEN; FEMALE; FEVER; HEADACHE; HOSPITAL; HUMAN; MAJOR CLINICAL STUDY; MALARIA FALCIPARUM; MALE; MIDDLE AGED; MONOTHERAPY; MULTICENTER STUDY; PHASE 2 CLINICAL TRIAL; PLASMODIUM FALCIPARUM; PRESCHOOL CHILD; PRIORITY JOURNAL; PRURITUS; QT PROLONGATION; RASH; SCHOOL CHILD; VOMITING; AGED; CLINICAL TRIAL; CONTROLLED STUDY; DRUG ADMINISTRATION; DRUG COMBINATION; DRUG EFFECTS; MALARIA, FALCIPARUM; PARASITOLOGY; PATHOLOGY; PHYSIOLOGY; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME;

ADOLESCENT; ADULT; AGED; AMINOQUINOLINES; ANTIMALARIALS; ARTEMISININS; CHILD; CHILD, PRESCHOOL; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; DRUG THERAPY, COMBINATION; FEMALE; FERROUS COMPOUNDS; HUMANS; MALARIA, FALCIPARUM; MALE; MIDDLE AGED; PLASMODIUM FALCIPARUM; TREATMENT OUTCOME;

EID: 84960366822     PISSN: 14733099     EISSN: 14744457     Source Type: Journal    
DOI: 10.1016/S1473-3099(15)00079-1     Document Type: Article

References (37)

1. World malaria report WHO, (accessed Jan 23, 2015). http://www.who.int/malaria/publications/world_malaria_report_2014/en/.
2. Kremsner PG, Krishna S Antimalarial combinations. Lancet 2004, 364:285-294.
3. Guidelines for the treatment of malaria 2010, WHO, World Health Organization, Geneva. 2nd edn.
4. Borrmann S, Adegnika AA, Missinou MA, et al. Short-course artesunate treatment of uncomplicated Plasmodium falciparum malaria in Gabon. Antimicrob Agents Chemother 2003, 47:901-904.
5. Noedl H, Se Y, Schaecher K, Smith BL, Socheat D, Fukuda MM Evidence of artemisinin-resistant malaria in western Cambodia. N Engl J Med 2008, 359:2619-2620.
6. Hawkes M, Conroy AL, Kain KC Spread of artemisinin resistance in malaria. N Engl J Med 2014, 371:1944-1945.
7. Biot C, Nosten F, Fraisse L, Ter-Minassian D, Khalife J, Dive D The antimalarial ferroquine: from bench to clinic. Parasite 2011, 18:207-214.
8. Barends M, Jaidee A, Khaohirun N, Singhasivanon P, Nosten F In vitro activity of ferroquine (SSR 97193) against Plasmodium falciparum isolates from the Thai-Burmese border. Malar J 2007, 6:81.
9. Atteke C, Ndong JM, Aubouy A, et al. In vitro susceptibility to a new antimalarial organometallic analogue, ferroquine, of Plasmodium falciparum isolates from the Haut-Ogooue region of Gabon. J Antimicrob Chemother 2003, 51:1021-1024.
10. Kreidenweiss A, Kremsner PG, Dietz K, Mordmuller B In vitro activity of ferroquine (SAR97193) is independent of chloroquine resistance in Plasmodium falciparum. Am J Trop Med Hyg 2006, 75:1178-1181.
11. Biot C, Glorian G, Maciejewski LA, Brocard JS Synthesis and antimalarial activity in vitro and in vivo of a new ferrocene-chloroquine analogue. J Med Chem 1997, 40:3715-3718.
12. Delhaes L, Abessolo H, Biot C, et al. In vitro and in vivo antimalarial activity of ferrochloroquine, a ferrocenyl analogue of chloroquine against chloroquine-resistant malaria parasites. Parasitol Res 2001, 87:239-244.
13. Daher W, Pelinski L, Klieber S, et al. In vitro metabolism of ferroquine (SSR97193) in animal and human hepatic models and antimalarial activity of major metabolites on Plasmodium falciparum. Drug Metab Dispos 2006, 34:667-682.
14. Mombo-Ngoma G, Supan C, Dal-Bianco MP, et al. Phase I randomized dose-ascending placebo-controlled trials of ferroquine-a candidate anti-malarial drug-in adults with asymptomatic Plasmodium falciparum infection. Malar J 2011, 10:53.
15. Supan C, Mombo-Ngoma G, Dal-Bianco MP, et al. Pharmacokinetics of ferroquine, a novel 4-aminoquinoline, in asymptomatic carriers of Plasmodium falciparum infections. Antimicrob Agents Chemother 2012, 56:3165-3173.
16. Methods and techniques for clinical trials on antimalarial drug efficacy: genotyping to identify parasite populations WHO, (accessed Jan 21, 2015). http://whqlibdoc.who.int/publications/2008/9789241596305_eng.pdf?ua=1.
17. Assessment and monitoring of antimalarial drug efficacy for the treatment of uncomplicated falciparum malaria 2003, WHO, World Health Organization, Geneva.
18. Naing C, Mak JW, Aung K, Wong JY Efficacy and safety of dihydroartemisinin-piperaquine for treatment of uncomplicated Plasmodium falciparum malaria in endemic countries: meta-analysis of randomised controlled studies. Trans R Soc Trop Med Hyg 2013, 107:65-73.
19. A head-to-head comparison of four artemisinin-based combinations for treating uncomplicated malaria in African children: a randomized trial. PLoS Med 2011, 8:e1001119. Four Artemisinin-Based Combinations Study Group.
20. Mordmuller B, Kremsner PG Malarial parasites vs. antimalarials: never-ending rumble in the jungle. Curr Mol Med 2006, 6:247-251.
21. Diem Thuy LT, Ngoc Hung L, Danh PT, Na-Bangchang K Absence of time-dependent artesunate pharmacokinetics in healthy subjects during 5-day oral administration. Eur J Clin Pharmacol 2008, 64:993-998.
22. Sridaran S, McClintock SK, Syphard LM, Herman KM, Barnwell JW, Udhayakumar V Anti-folate drug resistance in Africa: meta-analysis of reported dihydrofolate reductase (dhfr) and dihydropteroate synthase (dhps) mutant genotype frequencies in African Plasmodium falciparum parasite populations. Malar J 2010, 9:247.
23. Davis TM, Hung TY, Sim IK, Karunajeewa HA, Ilett KF Piperaquine: a resurgent antimalarial drug. Drugs 2005, 65:75-87.
24. Hall AP, Segal HE, Pearlman EJ, Phintuyothin P, Kosakal S Amodiaquine resistant falciparum malaria in Thailand. Am J Trop Med Hyg 1975, 24:575-580.
25. Marfurt J, Chalfein F, Prayoga P, et al. Ex vivo drug susceptibility of ferroquine against chloroquine-resistant isolates of Plasmodium falciparum and Plasmodium vivax. Antimicrob Agents Chemother 2011, 55:4461-4464.
26. Pradines B, Tall A, Rogier C, et al. In vitro activities of ferrochloroquine against 55 Senegalese isolates of Plasmodium falciparum in comparison with those of standard antimalarial drugs. Trop Med Int Health 2002, 7:265-270.
27. Henry M, Briolant S, Fontaine A, et al. In vitro activity of ferroquine is independent of polymorphisms in transport protein genes implicated in quinoline resistance in Plasmodium falciparum. Antimicrob Agents Chemother 2008, 52:2755-2759.
28. Borrmann S, Binder RK, Adegnika AA, et al. Reassessment of the resistance of Plasmodium falciparum to chloroquine in Gabon: implications for the validity of tests in vitro vs. in vivo. Trans R Soc Trop Med Hyg 2002, 96:660-663.
29. Ridley RG Medical need, scientific opportunity and the drive for antimalarial drugs. Nature 2002, 415:686-693.
30. Frank M, Lehners N, Mayengue PI, et al. A thirteen-year analysis of Plasmodium falciparum populations reveals high conservation of the mutant pfcrt haplotype despite the withdrawal of chloroquine from national treatment guidelines in Gabon. Malar J 2011, 10:304.
31. Ashley EA, Stepniewska K, Lindegardh N, et al. How much fat is necessary to optimize lumefantrine oral bioavailability?. Trop Med Int Health 2007, 12:195-200.
32. Sim IK, Davis TM, Ilett KF Effects of a high-fat meal on the relative oral bioavailability of piperaquine. Antimicrob Agents Chemother 2005, 49:2407-2411.
33. White NJ Cardiotoxicity of antimalarial drugs. Lancet Infect Dis 2007, 7:549-558.
34. Adjei GO, Oduro-Boatey C, Rodrigues OP, et al. Electrocardiographic study in Ghanaian children with uncomplicated malaria, treated with artesunate-amodiaquine or artemether-lumefantrine. Malar J 2012, 11:420.
35. Moore BR, Benjamin JM, Salman S, et al. Effect of coadministered fat on the tolerability, safety, and pharmacokinetic properties of dihydroartemisinin-piperaquine in Papua New Guinean children with uncomplicated malaria. Antimicrob Agents Chemother 2014, 58:5784-5794.
36. Narod S, Rosenblatt D, Lamothe E The banking of DNA for the prevention of genetic disease. Clin Invest Med 1991, 14:359-362.
37. Held J, Jeyaraj S, Kreidenweiss A Antimalarial compounds in Phase II clinical development. Expert Opin Investig Drugs 2015, 24:1-20.