Intermittent Preventive Treatment (IPTi) for the Prevention of Malaria and Anaemia in PNG Infants

This study has been completed.
Sponsor:
Collaborators:
University of Melbourne
Case Western Reserve University
Information provided by:
Papua New Guinea Institute of Medical Research
ClinicalTrials.gov Identifier:
NCT00285662
First received: February 1, 2006
Last updated: July 22, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention
Malaria
Anemia
Drug: Amodiaquine/sulphadoxine-pyrimethamine, Artesunate/sulphadoxine-pyrimethamine or placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Intermittent Preventive Treatment (IPTi) for the Prevention of Malaria and Anaemia in PNG Infants

Resource links provided by NLM:


Further study details as provided by Papua New Guinea Institute of Medical Research:

Primary Outcome Measures:
  • Incidence of symptomatic malaria (due to any Plasmodium species) from 3 - 15 months of age [ Time Frame: 15 months ] [ Designated as safety issue: No ]
  • Incidence of symptomatic P. falciparum malaria from 3 - 15 months of age [ Time Frame: 15 months ] [ Designated as safety issue: No ]
  • Incidence of symptomatic P. vivax malaria from 3-15 months of age [ Time Frame: !5 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of moderate-to-severe (Hb < 8 g/dl) and severe anaemia (Hb<5 g/dl) from 3 - 15 months of age [ Time Frame: 15 months ] [ Designated as safety issue: No ]
  • Mean haemoglobin concentration and prevalence of moderate-to-severe anaemia (Hb < 8 g/dl) at 15 months of age [ Time Frame: 15 months of age ] [ Designated as safety issue: No ]
  • Prevalence and density of malaria parasitemia at 15 months of age [ Time Frame: 15 months ] [ Designated as safety issue: No ]
  • Prevalence of splenomegaly at 15 months of age [ Time Frame: 15 months ] [ Designated as safety issue: No ]
  • Incidence of symptomatic malaria from 15 - 27 months of age [ Time Frame: 27 months ] [ Designated as safety issue: No ]
  • 9. Incidence of (symptomatic) moderate-to-severe (Hb < 8 g/dl) and severe anaemia (Hb<5 g/dl) from 15 - 27 months of age [ Time Frame: 27 months ] [ Designated as safety issue: No ]
  • 10. Mean haemoglobin levels and prevalence of moderate-to-severe (Hb < 8 g/dl) or severe anaemia at 27 months of age [ Time Frame: 27 months ] [ Designated as safety issue: No ]
  • 11. Prevalence and density of malaria parasitemia at 27 months of age [ Time Frame: 27 months ] [ Designated as safety issue: No ]
  • 12. Prevalence of splenomegaly at 27 months of age. [ Time Frame: 27 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 1100
Study Start Date: June 2006
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
1 day Sulfadoxine/Pyrimethamine + 3 days Amodiaquine
Drug: Amodiaquine/sulphadoxine-pyrimethamine, Artesunate/sulphadoxine-pyrimethamine or placebo
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
Active Comparator: 2
1 day of Sulfadoxine/Pyrimthamine and 3 days of Artesunate
Drug: Amodiaquine/sulphadoxine-pyrimethamine, Artesunate/sulphadoxine-pyrimethamine or placebo
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
Placebo Comparator: 3
children of this gorup will receive only placebo dugs
Drug: Amodiaquine/sulphadoxine-pyrimethamine, Artesunate/sulphadoxine-pyrimethamine or placebo
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

Detailed Description:

Intermittent preventive treatment in infancy (IPTi) is one of the most promising recent interventions to reduce the devastating impact of malaria in early childhood. Although two African studies have provided the proof of principle, further studies are needed to address several key issues. IPTi needs additional evaluation in a variety of settings and populations, alternative drugs and treatment schedules need to be tested and the long-term effect of IPTi on risk of malaria illness through early childhood needs to be clarified.

Many of these issues are currently being addressed in a series of studies conducted under the auspice of the IPTi Consortium. However, all these studies are based in sub-Saharan Africa and are thus almost exclusively concerned with the potential of IPTi to prevent P. falciparum malaria.

In order to determine whether IPTi is also an effective intervention in areas where there is a high prevalence of non-falciparum infections, further studies outside Africa are urgently needed. In addition, although initial IPTi studies have not shown a rebound in malaria morbidity following the intervention, the influence of IPTi on the acquisition of functional malaria immunity needs further investigation.

This proposal brings together investigators, experience, and resources to conduct a clinical trial of IPTi complemented by careful epidemiologic and laboratory investigations in two highly endemic areas of Papua New Guinea, where infections with all 4 human Plasmodium species are common. The studies will be based at the PNG Institute for Medical Research, which has excellent infrastructure and a strong history of malaria research and community-based studies

  Eligibility

Ages Eligible for Study:   2 Months to 4 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00285662

Locations
Papua New Guinea
Papua New Guinea Institute of Medical Research
Goroka, Papua New Guinea
Sponsors and Collaborators
Papua New Guinea Institute of Medical Research
University of Melbourne
Case Western Reserve University
Investigators
Principal Investigator: Ivo Mueller, PhD Papua New Guinea Institute of Medical Research
Principal Investigator: John Reeder, Prof Papua New Guinea Institute of Medical Research
  More Information

No publications provided by Papua New Guinea Institute of Medical Research

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof Peter Siba, PNG Institute of Medical Research
ClinicalTrials.gov Identifier: NCT00285662     History of Changes
Other Study ID Numbers: IPTi219
Study First Received: February 1, 2006
Last Updated: July 22, 2011
Health Authority: Australia: National Health and Medical Research Council

Keywords provided by Papua New Guinea Institute of Medical Research:
IPTi
Malaria
Anemia
Prevention
Infant
Artesunate
SP
Amodiaquine
Papua New Guinea

Additional relevant MeSH terms:
Anemia
Malaria
Hematologic Diseases
Protozoan Infections
Parasitic Diseases
Amodiaquine
Pyrimethamine
Sulfadoxine
Artesunate
Sulfadoxine-pyrimethamine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents
Amebicides

ClinicalTrials.gov processed this record on April 17, 2014