NCT00285662

Brief Summary

In malaria-endemic areas, young children have an especially high risk of malaria morbidity and mortality. Malaria is estimated to cause up to 2 million deaths and 500 million clinical episodes in Africa alone. The bulk of disease in Africa and severe disease and deaths globally is due to P. falciparum. However, P. vivax is also responsible for a substantial disease burden in endemic regions outside Africa, where P. vivax may account for more than half of all malaria cases. Efforts to reduce this unacceptably high disease burden are hampered by the limited availability of affordable interventions. Following the cessation of large-scale vector control in highly endemic areas, malaria control efforts have centred on early diagnosis and treatment of clinical cases and reducing exposure through the use of insecticide-treated nets (ITNs). While ITNs have been shown to significantly reduce the burden of malaria additional effective interventions are urgently needed. Several trials have shown that chemoprophylaxis given to children at weekly or fortnightly intervals reduces morbidity from malaria in a number of different settings and populations. An alternative approach has been to use intermittent preventive therapy (IPT) involving the administration of a full therapeutic dose of antimalarials at regular intervals. This is logistically easier to deliver, and is less costly, and may reduce problems of promoting drug resistance associated with regular chemoprophylaxis. Intermittent administration of sulphadoxine-pyrimethamine (SP) during antenatal clinic visits was shown to be highly effective in reducing malaria and anaemia in pregnant women and improving infant birth weights. IPT in pregnancy (IPTp) is now recommended by WHO for endemic regions of Africa.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,100

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2006

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2006

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

July 25, 2011

Status Verified

July 1, 2011

Enrollment Period

3.9 years

First QC Date

February 1, 2006

Last Update Submit

July 22, 2011

Conditions

MalariaAnemia

Keywords

IPTiMalariaAnemiaPreventionInfantArtesunateSPAmodiaquinePapua New Guinea

Outcome Measures

Primary Outcomes (3)

  • Incidence of symptomatic malaria (due to any Plasmodium species) from 3 - 15 months of age

    15 months

  • Incidence of symptomatic P. falciparum malaria from 3 - 15 months of age

    15 months

  • Incidence of symptomatic P. vivax malaria from 3-15 months of age

    !5 months

Secondary Outcomes (9)

  • Incidence of moderate-to-severe (Hb < 8 g/dl) and severe anaemia (Hb<5 g/dl) from 3 - 15 months of age

    15 months

  • Mean haemoglobin concentration and prevalence of moderate-to-severe anaemia (Hb < 8 g/dl) at 15 months of age

    15 months of age

  • Prevalence and density of malaria parasitemia at 15 months of age

    15 months

  • Prevalence of splenomegaly at 15 months of age

    15 months

  • Incidence of symptomatic malaria from 15 - 27 months of age

    27 months

  • +4 more secondary outcomes

Study Arms (3)

1

ACTIVE COMPARATOR

1 day Sulfadoxine/Pyrimethamine + 3 days Amodiaquine

Drug: Amodiaquine/sulphadoxine-pyrimethamine, Artesunate/sulphadoxine-pyrimethamine or placebo

2

ACTIVE COMPARATOR

1 day of Sulfadoxine/Pyrimthamine and 3 days of Artesunate

Drug: Amodiaquine/sulphadoxine-pyrimethamine, Artesunate/sulphadoxine-pyrimethamine or placebo

3

PLACEBO COMPARATOR

children of this gorup will receive only placebo dugs

Drug: Amodiaquine/sulphadoxine-pyrimethamine, Artesunate/sulphadoxine-pyrimethamine or placebo

Interventions

Amodiaquine/sulphadoxine-pyrimethamine, Artesunate/sulphadoxine-pyrimethamine or placeboDRUG

Children will get 25mg/1.25mg/kg of SP as a single dose, 4 mg/kg for 3 days of Artesunate and 10 mg/kg for 3 days of Amodiaquine in their respective arms

123

Eligibility Criteria

Age2 Months - 4 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • months old living in the aera for the next 2 years, exlusive use of the study health facilities

You may not qualify if:

  • Known chronic illness, e.g. TB, diabetes, renal failure severe malnutrition (weight-for-age (WAZ) \< 60% percentile) severe anaemia (Hb \< 5 g/dl), or permanent disability, that prevents or impedes study participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Papua New Guinea Institute of Medical Research

Goroka, Papua New Guinea

Location

Related Publications (3)

  • Senn N, Rarau P, Manong D, Salib M, Siba P, Reeder JC, Rogerson SJ, Genton B, Mueller I. Effectiveness of artemether/lumefantrine for the treatment of uncomplicated Plasmodium vivax and P. falciparum malaria in young children in Papua New Guinea. Clin Infect Dis. 2013 May;56(10):1413-20. doi: 10.1093/cid/cit068. Epub 2013 Feb 12.

    PMID: 23403171DERIVED

  • Senn N, Rarau P, Stanisic DI, Robinson L, Barnadas C, Manong D, Salib M, Iga J, Tarongka N, Ley S, Rosanas-Urgell A, Aponte JJ, Zimmerman PA, Beeson JG, Schofield L, Siba P, Rogerson SJ, Reeder JC, Mueller I. Intermittent preventive treatment for malaria in Papua New Guinean infants exposed to Plasmodium falciparum and P. vivax: a randomized controlled trial. PLoS Med. 2012;9(3):e1001195. doi: 10.1371/journal.pmed.1001195. Epub 2012 Mar 27.

    PMID: 22479155DERIVED

  • Senn N, Rarau P, Manong D, Salib M, Siba P, Robinson LJ, Reeder J, Rogerson S, Mueller I, Genton B. Rapid diagnostic test-based management of malaria: an effectiveness study in Papua New Guinean infants with Plasmodium falciparum and Plasmodium vivax malaria. Clin Infect Dis. 2012 Mar 1;54(5):644-51. doi: 10.1093/cid/cir901. Epub 2011 Dec 23.

    PMID: 22198787DERIVED

MeSH Terms

Conditions

MalariaAnemia

Interventions

Amodiaquinefanasil, pyrimethamine drug combination

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

AminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Ivo Mueller, PhD

    Papua New Guinea Institute of Medical Research

    PRINCIPAL INVESTIGATOR

  • John Reeder, Prof

    Papua New Guinea Institute of Medical Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

February 1, 2006

First Posted

February 2, 2006

Study Start

June 1, 2006

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

July 25, 2011

Record last verified: 2011-07

Locations

PA(1)