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Efficacy of Three ACTs for the Treatment of Falciparum Malaria in Maradi Niger

Primary Purpose

Malaria

Status

Completed

Phase

Phase 4

Locations

Niger

Study Type

Interventional

Intervention

Artesunate-amodiaquine

Dihydroartemisinin-piperaquine

Artemether-lumefantrine

About this trial

This is an interventional treatment trial for Malaria focused on measuring malaria, artemisinin, artemisinin-based combination therapies, Plasmodium falciparum, efficacy

Eligibility Criteria

6 Months - 59 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age between 6 and 59 months
Weight ≥ 5 kg
Mono-infection with P. falciparum detected by microscopy
Parasitic density between 2,000 and 200,000 asexual forms /µL of blood
Axillary temperature ≥ 37.5°C or history of fever during the previous 24 hours
Ability and willingness to comply with the protocol for the duration of the study and to comply with the study visit schedule (home is within one hour of walk from the outpatient department, no near-term travel plans, etc.)
Consent of a parent or guardian who is at least 18 years of age.

Exclusion Criteria:

Presence of general danger signs as defined by the WHO,
Presence of signs of severe malaria according to the definitions of WHO,
Severe anemia (haemoglobin <5 g/dL),
Known history of symptomatic cardiac arrhythmias or with clinically relevant bradycardia,
Family history of sudden death or of congenital prolongation of corrected QT interval,
Use of antiarrhythmics or neuroleptics,
Known history of hypersensitivity to any of the study medications,
Severe malnutrition (defined as a weight-height ratio of < -3 z-score according to the 2006 WHO reference (20) and / or a mid-upper arm circumference lower than 115 mm and / or the presence of symmetrical oedema of the feet),
Presence of a febrile condition due to a disease other than malaria (i.e. measles, acute lower respiratory tract infection, otitis media, tonsillitis, abscess, severe diarrhoea with dehydration, etc.)
History of a full treatment course with one of the three study drugs in the past 28 days. The prior incomplete intake of one of the three study drugs or prior intake of antimalarial drugs not being tested in the study does not exclude a patient from participating in this study. However, information on these previous treatments will be carefully recorded.

Sites / Locations

Andoumé Health Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Arm Label

Artesunate-amodiaquine

Dihydroartemisinin-piperaquine

Artemether-lumefantrine

Arm Description

Efficacy estimates at 95%

Outcomes

Primary Outcome Measures

Adequate clinical and parasitological response

Absence of parasitaemia on day 42, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure, late clinical failure or late parasitological failure.

Secondary Outcome Measures

Early treatment failure

General danger signs or signs of severe malaria on days 1, 2, or 3, in the presence of parasitaemia , or Parasitaemia on day 2 higher than on day 0, irrespective of axillary temperature, or Parasitaemia on day 3 with axillary temperature ≥ 37.5°C, or Parasitaemia on day 3 ≥ 25% count on day 0 irrespective of axillary temperature.

Late clinical failure

General danger signs or severe malaria in the presence of parasitaemia on any day between day 4 and day 42 in patients who did not previously meet any of the criteria of early treatment failure; or Presence of parasitaemia on any day between day 4 and day 42 with axillary temperature ≥ 37.5 °C in patients who did not previously meet any of the criteria of early treatment failure.

Late Parasitological Failure

- Presence of parasitaemia on any day between day 7 and day 42 with axillary temperature < 37.5 °C in patients who did not previously meet any of the criteria of early treatment failure or late clinical failure.

Full Information

NCT ID

NCT01755559

First Posted

December 19, 2012

Last Updated

November 26, 2015

Sponsor

Epicentre

Collaborators

Centre de Recherche Médicale et Sanitaire (Cermes), Niamey

1. Study Identification

Unique Protocol Identification Number

NCT01755559

Brief Title

Efficacy of Three ACTs for the Treatment of Falciparum Malaria in Maradi Niger

Official Title

Efficacy of Artesunate-amodiaquine, Dihydroartemisinin-piperaquine and Artemether-lumefantrine Combination Therapies for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Children Aged 6 to 59 Months in Maradi, Niger 2012-13

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Completed

Study Start Date

June 2013 (undefined)

Primary Completion Date

November 2014 (Actual)

Study Completion Date

November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Epicentre

Collaborators

Centre de Recherche Médicale et Sanitaire (Cermes), Niamey

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Study treatments: Artemether-lumefantrine Artesunate-amodiaquine Dihydroartemisinin-piperaquine Location: Maradi, Niger Principal Objective: To measure the clinical and parasitological efficacy of the three artemisinin combination therapies over a period of 42 days from the start of treatment and with polymerase chain reaction assay (PCR) adjustment. Secondary objectives: To determine the blood concentration of the non-artemisinin component of the treatment (lumefantrine, desethylamodiaquine or piperaquine) at day 7 To assess the incidence of adverse events during the follow-up period; To measure speed of parasite clearance Methods: In vivo non comparative study as for WHO standardised protocol. The study also measure the concentration of the non-artemisinin component. Target population: Children under 5 years of age consulting the integrated health centres of Andoumé and Dix-sept portes in Maradi. Sample size: 221 patients per study treatment; 663 patients in total. Treatment allocation: Random. Outcomes: Early treatment failure, Late clinical failure, Late parasitological failure, Adequate clinical and parasitological response. Analysis: Cumulative success or failure rate (Kaplan-Meier analysis). Proportions of early treatment failures, late clinical failures, late parasitological failures, and adequate clinical and parasitological response (called also Per-protocol analysis).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malaria

Keywords

malaria, artemisinin, artemisinin-based combination therapies, Plasmodium falciparum, efficacy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

663 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Artesunate-amodiaquine

Arm Type

Other

Arm Description

Efficacy estimates at 95%

Arm Title

Dihydroartemisinin-piperaquine

Arm Type

Other

Arm Description

Efficacy estimates at 95%

Arm Title

Artemether-lumefantrine

Arm Type

Other

Arm Description

Efficacy estimates at 95%

Intervention Type

Drug

Intervention Name(s)

Artesunate-amodiaquine

Other Intervention Name(s)

AS-AQ Winthrop® Sanofi Aventis

Intervention Description

antimalarial ACT

Intervention Type

Drug

Intervention Name(s)

Dihydroartemisinin-piperaquine

Other Intervention Name(s)

Euratesim, Sigma-Tau

Intervention Description

antimalarial ACT

Intervention Type

Drug

Intervention Name(s)

Artemether-lumefantrine

Other Intervention Name(s)

Coartem, Novartis

Intervention Description

antimalarial ACT

Primary Outcome Measure Information:

Title

Adequate clinical and parasitological response

Description

Time Frame

42 days after treatement start

Secondary Outcome Measure Information:

Title

Early treatment failure

Description

Time Frame

1 to 3 days after tratment start

Title

Late clinical failure

Description

Time Frame

from day 4 to day 42 after treatment start

Title

Late Parasitological Failure

Description

Time Frame

from day 7 to day 42 after treatment start

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

59 Months

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age between 6 and 59 months Weight ≥ 5 kg Mono-infection with P. falciparum detected by microscopy Parasitic density between 2,000 and 200,000 asexual forms /µL of blood Axillary temperature ≥ 37.5°C or history of fever during the previous 24 hours Ability and willingness to comply with the protocol for the duration of the study and to comply with the study visit schedule (home is within one hour of walk from the outpatient department, no near-term travel plans, etc.) Consent of a parent or guardian who is at least 18 years of age. Exclusion Criteria: Presence of general danger signs as defined by the WHO, Presence of signs of severe malaria according to the definitions of WHO, Severe anemia (haemoglobin <5 g/dL), Known history of symptomatic cardiac arrhythmias or with clinically relevant bradycardia, Family history of sudden death or of congenital prolongation of corrected QT interval, Use of antiarrhythmics or neuroleptics, Known history of hypersensitivity to any of the study medications, Severe malnutrition (defined as a weight-height ratio of < -3 z-score according to the 2006 WHO reference (20) and / or a mid-upper arm circumference lower than 115 mm and / or the presence of symmetrical oedema of the feet), Presence of a febrile condition due to a disease other than malaria (i.e. measles, acute lower respiratory tract infection, otitis media, tonsillitis, abscess, severe diarrhoea with dehydration, etc.) History of a full treatment course with one of the three study drugs in the past 28 days. The prior incomplete intake of one of the three study drugs or prior intake of antimalarial drugs not being tested in the study does not exclude a patient from participating in this study. However, information on these previous treatments will be carefully recorded.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Francesco Grandesso, MSc

Organizational Affiliation

Epicentre

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Lynda Woi Messe, MD

Organizational Affiliation

Epicentre

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Ibrahim M Laminou, PhD

Organizational Affiliation

Cermes

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Jean-François Etard, PhD

Organizational Affiliation

Epicentre

Official's Role

Study Chair

Facility Information:

Facility Name

Andoumé Health Centre

City

Maradi

Country

Niger

12. IPD Sharing Statement

Citations:

PubMed Identifier

29370844

Citation

Grandesso F, Guindo O, Woi Messe L, Makarimi R, Traore A, Dama S, Laminou IM, Rigal J, de Smet M, Ouwe Missi Oukem-Boyer O, Doumbo OK, Djimde A, Etard JF. Efficacy of artesunate-amodiaquine, dihydroartemisinin-piperaquine and artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Maradi, Niger. Malar J. 2018 Jan 25;17(1):52. doi: 10.1186/s12936-018-2200-1.

Results Reference

derived

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Efficacy of Three ACTs for the Treatment of Falciparum Malaria in Maradi Niger

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