MalariaNCT00285662
Intermittent Preventive Treatment (IPTi) for the Prevention of Malaria and Anaemia in PNG Infants
A study of Malaria and Anemia, run by Papua New Guinea Institute of Medical Research at 1 site in Papua New Guinea.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 4 monthsHealthy volunteers can take part
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,100 participants
- Where
- 1 sitePapua New Guinea
- Study dates
- Jun 2006to May 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 4 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 3 months old living in the aera for the next 2 years, exlusive use of the study health facilities
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Papua New Guinea1 site
Papua New Guinea Institute of Medical Research
Goroka
About this study
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.
Read the 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
- Being tested
- Amodiaquine/sulphadoxine-pyrimethamine, Artesunate/sulphadoxine-pyrimethamine or placebo
- Keywords
- IPTi, Malaria, Anemia, Prevention, Infant, Artesunate, SP, Amodiaquine, Papua New Guinea
- Medical subject headings
- Malaria, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 1 day Sulfadoxine/Pyrimethamine + 3 days Amodiaquine Receives: Drug: Amodiaquine/sulphadoxine-pyrimethamine, Artesunate/sulphadoxine-pyrimethamine or placebo |
| 2 | Active comparator | 1 day of Sulfadoxine/Pyrimthamine and 3 days of Artesunate Receives: Drug: Amodiaquine/sulphadoxine-pyrimethamine, Artesunate/sulphadoxine-pyrimethamine or placebo |
| 3 | Placebo comparator | children of this gorup will receive only placebo dugs Receives: Drug: Amodiaquine/sulphadoxine-pyrimethamine, Artesunate/sulphadoxine-pyrimethamine or placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of symptomatic malaria (due to any Plasmodium species) from 3 - 15 months of age
Measured: 15 months
Incidence of symptomatic P. falciparum malaria from 3 - 15 months of age
Measured: 15 months
Incidence of symptomatic P. vivax malaria from 3-15 months of age
Measured: !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
Measured: 15 months
Mean haemoglobin concentration and prevalence of moderate-to-severe anaemia (Hb < 8 g/dl) at 15 months of age
Measured: 15 months of age
Prevalence and density of malaria parasitemia at 15 months of age
Measured: 15 months
Prevalence of splenomegaly at 15 months of age
Measured: 15 months
Incidence of symptomatic malaria from 15 - 27 months of age
Measured: 27 months
9. Incidence of (symptomatic) moderate-to-severe (Hb < 8 g/dl) and severe anaemia (Hb<5 g/dl) from 15 - 27 months of age
Measured: 27 months
10. Mean haemoglobin levels and prevalence of moderate-to-severe (Hb < 8 g/dl) or severe anaemia at 27 months of age
Measured: 27 months
11. Prevalence and density of malaria parasitemia at 27 months of age
Measured: 27 months
12. Prevalence of splenomegaly at 27 months of age.
Measured: 27 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2006 (estimated)
- Study startJun 2006
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Papua New Guinea Institute of Medical Research
- Sponsor type
- Other government
- Collaborators
- University of Melbourne, Case Western Reserve University
- Investigators
- Ivo Mueller, PhD, Principal investigator, Papua New Guinea Institute of Medical ResearchJohn Reeder, Prof, Principal investigator, Papua New Guinea Institute of Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00285662
- Sponsor's protocol ID
- IPTi219
- Status last verified
- Jul 2011
- First submitted
- 1 Feb 2006
- Last updated
- 25 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23403171Senn 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.
PubMed 22479155Senn 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.
PubMed 22198787
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Preventive Treatment (IPTi) for the Prevention of Malaria and Anaemia in PNG Infants
- ClinicalTrials.gov ID
- NCT00285662
- Acronym / sponsor ID
- IPTi219
- Keywords
- IPTi, Malaria, Anemia, Prevention, Infant, Artesunate, SP, Amodiaquine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- Papua New Guinea Institute of Medical ResearchOther government
- Collaborators
- University of Melbourne, Case Western Reserve University
- Study start
- Jun 2006
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 2 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Amodiaquine/sulphadoxine-pyrimethamine, Artesunate/sulphadoxine-pyrimethamine or placebo1 day Sulfadoxine/Pyrimethamine + 3 days Amodiaquine |
| 2 | Active comparator | Drug: Amodiaquine/sulphadoxine-pyrimethamine, Artesunate/sulphadoxine-pyrimethamine or placebo1 day of Sulfadoxine/Pyrimthamine and 3 days of Artesunate |
| 3 | Placebo comparator | Drug: Amodiaquine/sulphadoxine-pyrimethamine, Artesunate/sulphadoxine-pyrimethamine or placebochildren of this gorup will receive only placebo dugs |
Who may qualify
- Ages
- 2 to 4 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 3 months old living in the aera for the next 2 years, exlusive use of the study health facilities
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amodiaquine/sulphadoxine-pyrimethamine, Artesunate/sulphadoxine-pyrimethamine or placeboChildren 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 | Drug | 1, 2, 3 |
Primary outcome
Incidence of symptomatic malaria (due to any Plasmodium species) from 3 - 15 months of age
Time frame: 15 months
Incidence of symptomatic P. falciparum malaria from 3 - 15 months of age
Time frame: 15 months
Incidence of symptomatic P. vivax malaria from 3-15 months of age
Time frame: !5 months
9 secondary outcomes
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
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
Prevalence and density of malaria parasitemia at 15 months of age
Time frame: 15 months
Prevalence of splenomegaly at 15 months of age
Time frame: 15 months
Incidence of symptomatic malaria from 15 - 27 months of age
Time frame: 27 months
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
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
11. Prevalence and density of malaria parasitemia at 27 months of age
Time frame: 27 months
12. Prevalence of splenomegaly at 27 months of age.
Time frame: 27 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2011.
- Derived from this study: PubMed 23403171Senn 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.
- Derived from this study: PubMed 22479155Senn 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.
- Derived from this study: PubMed 22198787Senn 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ivo Mueller, PhD principal investigator
Papua New Guinea Institute of Medical Research
John Reeder, Prof principal investigator
Papua New Guinea Institute of Medical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Malaria and Anemia, run by Papua New Guinea Institute of Medical Research at 1 site in Papua New Guinea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Papua New Guinea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of symptomatic malaria (due to any Plasmodium species) from 3 - 15 months of age (time frame: 15 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00285662, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2011.