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HealthyPhase 3PIP-IPTNCT01722539

Impact IPT With Sulfadoxine-pyrimethamine or Sulfadoxine-pyrimethamine Plus Piperaquine in Schoolchildren

A Phase 3 study testing Sulfadoxine-pyrimethamine, Piperaquine and Albendazole in people with Healthy, run by Universiteit Antwerpen at 1 site in Republic of the Congo.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Considering the facts that: (i) IPT of malaria provides substantial protection against anaemia and malaria in school children (ii); SP resistance has no significant impact on the prophylactic efficacy (iii) SP-PQ is safe and as efficacious as SP: the investigators hypothesize that antimalarial IPT with SP and SP-PQ… Read more about this study

Who is it for?
Ages 5 to 14 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Sulfadoxine-pyrimethamine, Piperaquine and Albendazole
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
616 participants
Where
1 siteRepublic of the Congo
Study dates
Nov 2012to Nov 2013
Phase
Phase 3
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 5 to 14 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • males and females in primary school children,
  • anticipated local residence for the study duration,
  • signed or thumb-printed informed consent by the parents or guardians and witnessed by an impartial witness (whenever parents/guardians are illiterate)

Who cannot join

  • Children of the 6th primary school year
  • Participation in any other investigational drug study (antimalarial or others) during the previous 30 days.
  • Known hypersensitivity or serious adverse drug reaction (ADR) to the study drugs.
  • Clinical malaria at baseline irrespectively of the severity (World Health Organisation malaria treatment guideline 2010) (Annex III).
  • Febrile conditions caused by diseases other than malaria at first visit.
  • Clinical symptoms of severe anaemia
  • Illness or conditions like hematologic, cardiac, renal, hepatic diseases which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study, including known Glucose 6 phospahate dehydrogenase (G6PD) deficiency and sickle cell (SS form).
  • Body weight < 14 kg Children with major chronic infectious diseases (HIV, Tuberculosis, ...)

Trial locations and contacts

1 site in 1 country.

Republic of the Congo1 site

  • Mokali health area of Biyela health zone, in Kinshasa province.

    Kinshasa, Kinshasa Province

Other trials in Republic of the Congo

About this study

Official title: Efficacy and Safety of Sulfadoxine-pyrimethamine or Sulfadoxine-pyrimethamine Plus Piperaquine Regimens Delivered Through Intermittent Preventive Treatment in Schoolchildren of Democratic Republic of Congo: A Randomised Control Trial

Considering the facts that: (i) IPT of malaria provides substantial protection against anaemia and malaria in school children (ii); SP resistance has no significant impact on the prophylactic efficacy (iii) SP-PQ is safe and as efficacious as SP: the investigators hypothesize that antimalarial IPT with SP and SP-PQ will improve haemoglobin concentration, reduce anaemia prevalence, malaria incidence and parasitaemia, and improve malnutrition and school performance in school-aged children of Congo.

Read the detailed description

STUDY RATIONAL The education sector represents a reliable system for malaria control. Intermittent preventive therapy in schoolchildren (IPTsc) is likely the most feasible and appropriate chemoprevention in stable and endemic areas because schoolchildren are usually asymptomatic to malaria infection and are consequently untreated in practice. Therefore, if proven effective, IPTsc would be of direct benefit for the schoolchild, contribute to malaria control at school, and facilitate community-wide the implementation of other control interventions i.e. vector control, Intermittent preventive therapy in infants (IPTi), and prompt diagnosis and treatment (PDT). Nevertheless, evidence about use of IPTsc is not yet substantiated as only two clinical studies have so far been performed on IPTsc in hyper endemic areas. Further clinical trials are warranted in other settings. Through a randomised controlled trial (RCT) we will assess the efficacy and safety, of two IPT regimens versus controls in school children of the DRCongo.

STUDY DRUGS Favourable drugs for use as IPT should balance long half-life against efficacy, safety, tolerability and potentiality for cross-resistance selection.(16) Use of long-acting drugs would result in fewer intake and higher treatment compliance. Sulfadoxine-pyrimethamine is an established used product in the indication of IPT in pregnancy. The drug has further proven safety and tolerability in children in clinical trials. SP is slowly eliminated and allows 60 days antimalaria protection for fully sensitive P. falciparum. Other long-acting drugs available are mefloquine, amodiaquine, and piperaquine. However, due safety concern mefloquine might not be optimal for IPT. Amodiaquine is not suitable for IPT due to its 3 days treatment regimen that may be a concern regarding compliance. Piperaquine has been extensively used for mass prophylaxis and treatment since 1978 in China and other malaria endemic countries of Asia.(20) Piperaquine has a long half-live and points as good IPT candidate in endemic country with SP resistance. For this study sulfadoxine-pyrimethamine combined with piperaquine (SP-PQ) plus will be used. SP and SP-PQ will be given at 4 months intervals in line with the long half-lives (around 20 days) in paediatric patients and for higher treatment compliance,

Conditions
Healthy
Being tested
Sulfadoxine-pyrimethamine, Piperaquine, Albendazole, Praziquantel
Keywords
intermittent, preventive, treatment, malaria, soil transmitted helminths, schistosomiasis, schoolchildren
Medical subject headings
Malaria, Schistosomiasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sulfadoxine-pyrimethamineDrug

    Also called Fansidar

    Tablets 500 mg sulfadoxine - 25 mg pyrimethamine will be given as single oral dose of ½ tablets per 10 kg of weigh: 1 tablet for weigh less than 20 kg, 1.5 tablets in 20-29 kg, and 2 tablets for children of weigh 30 or more

  • PiperaquineDrug

    Piperaquine tablet 320 mg manufactured by Sigma Tau will be used at two treatment doses of 16-24 mg/kg at 24 hours intervals as follows: 1 tablets for weigh 15-19 kg, 1.5 tablets for 20-29 kg, and 2 tablets for 30-39 kg, and 2.5 tablets for 40 kg or more.

  • AlbendazoleDrug

    One oral 200 mg will be given to children of 1-2 years and one oral dose of 400 mg to children older than 2 years. The treatment will be repeated at 4-months in the follow-up in accordance with the WHO guideline.

  • PraziquantelDrug

    Praziquantel is a tremacide used for treatment of infections due to schistosomes. Praziquantel will be given as one dose of 40 mg/kg at enrolment and at 12 months follow up.

Study groups in NCT01722539
Study groupRoleWhat they receive
Sulfadoxine-PyrimethamineExperimentalSulfadoxine-Pyrimethamine every Four months Tablets 500 mg sulfadoxine - 25 mg pyrimethamine will be given as single oral dose of ½ tablets per 10 kg of weigh: 1 tablet for weigh less than 20 kg, 1.5 tablets in 20-29 kg, and 2 tablets for children of weigh 30 or more; Albendazole oral 200 mg will be given to children of 1-2 years and one oral dose of 400 mg to children older than 2 years. The treatment will be repeated at 4-months in the follow-up in accordance with the WHO guideline. Praziquantel is a tremacide used for treatment of infections due to schistosomes. Praziquantel will be given as one dose of 40 mg/kg at enrolment and at 12 months follow up.
Receives: Drug: Sulfadoxine-pyrimethamine; Drug: Piperaquine; Drug: Albendazole; Drug: Praziquantel
Sulfadoxine-Pyrimethamine+PiperaquineExperimentalSulfadoxine-Pyrimethamine every 4 months Tablets 500 mg sulfadoxine - 25 mg pyrimethamine will be given as single oral dose of ½ tablets per 10 kg of weigh: 1 tablet for weigh less than 20 kg, 1.5 tablets in 20-29 kg, and 2 tablets for children of weigh 30 or more; Piperaquine every four months Piperaquine tablet 320 mg manufactured by Sigma Tau will be used at two treatment doses of 16-24 mg/kg at 24 hours intervals as follows: 1 tablets for weigh 15-19 kg, 1.5 tablets for 20-29 kg, and 2 tablets for 30-39 kg, and 2.5 tablets for 40 kg or more. Albendazole oral 200 mg will be given to children of 1-2 years and one oral dose of 400 mg to children older than 2 years. The treatment will be repeated at 4-months in the follow-up in accordance with the WHO guideline. Praziquantel is a tremacide used for treatment of infections due to schistosomes. Praziquantel will be given as one dose of 40 mg/kg at enrolment and at 12 months follow up.
Receives: Drug: Piperaquine; Drug: Albendazole; Drug: Praziquantel
ControlActive comparatorAlbendazole oral 200 mg will be given to children of 1-2 years and one oral dose of 400 mg to children older than 2 years. The treatment will be repeated at 4-months in the follow-up in accordance with the WHO guideline. Praziquantel is a tremacide used for treatment of infections due to schistosomes. Praziquantel will be given as one dose of 40 mg/kg at enrolment and at 12 months follow up.
Receives: Drug: Albendazole; Drug: Praziquantel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hemoglobin change

    Change in mean Hb concentration at month 12 of follow-up and anaemia prevalence one year after initial preventive treatment;

    Measured: Month 0-Month 12

Secondary outcomes (8)

  1. Change in mean Hb concentration at month 4 and 8 of follow-up

    Measured: Month 0 - Month 4 - Month 8

  2. Prevalence of asymptomatic and clinical malaria at baseline & one year after enrolment;

    Measured: Month 0 Month 12

  3. Prevalence of P. falciparum dihydrofolate reductase (dhfr) and dihydropteroate synthase (dhps) gene mutations at baseline and at month 12 follow-up

    Measured: Month 0 - Month 12

  4. Clinical (severe) malaria incidence and parasitaemia at month 4, 8, 12;

    Measured: Month 4, 8 12

  5. Percentages of acute and severe malnourished at month 0, 4, 8, 12 through z-scores, W/H, H/A, and skinfolds

    Measured: Month 0 - Month 12

  6. Educational achievement, at end of follow-up, and school attendance;

    Measured: Month 0 - Month 12

  7. Prevalence and risk of environmental and host-related predictors for malaria (re)infections;

    Measured: Month 0- Month 12

  8. adverse events

    Measured: Month 0- Months 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2012 (estimated)
  2. Study startNov 2012
  3. Primary completionNov 2013
  4. Study completionNov 2013

Resources

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
616 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01722539
Sponsor's protocol ID
PIP-IPT
Acronym
PIP-IPT
Status last verified
Feb 2014
First submitted
3 Nov 2012
Last updated
4 Feb 2014
Results posted
No
Data monitoring committee
No

Publications

  • Doua JY, Matangila J, Lutumba P, Van Geertruyden JP. Intermittent preventive treatment: efficacy and safety of sulfadoxine-pyrimethamine and sulfadoxine-pyrimethamine plus piperaquine regimens in schoolchildren of the Democratic Republic of Congo: a study protocol for a randomized controlled trial. Trials. 2013 Sep 24;14:311. doi: 10.1186/1745-6215-14-311.

    PubMed 24063608

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sulfadoxine-pyrimethamine, Piperaquine and Albendazole in people with Healthy, run by Universiteit Antwerpen at 1 site in Republic of the Congo.

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 3 inclusion and 8 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 4 Feb 2014. 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 Republic of the Congo. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Hemoglobin change (time frame: Month 0-Month 12). 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 NCT01722539, which also lists 1 linked publication.

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 4 Feb 2014.

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