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

NCT01722539 | Completed Phase 3

• 1 other identifier: PIP-IPT
• Study Type: interventional
• Target: 616
• Locations: 1 country
• Sites: 1

Brief 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 will improve haemoglobin concentration, reduce anaemia prevalence, malaria incidence and parasitaemia, and improve malnutrition and school performance in school-aged children of Congo.

Conditions

Healthy

Keywords

intermittent; preventive; treatment; malaria; soil transmitted helminths; schistosomiasis; schoolchildren

Outcome Measures

Primary Outcomes (1)

• Hemoglobin change

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

  Month 0-Month 12

Secondary Outcomes (8)

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

  Month 0 - Month 4 - Month 8

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

  Month 0 Month 12

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

  Month 0 - Month 12

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

  Month 4, 8 12

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

  Month 0 - Month 12

Study Arms (3)

Sulfadoxine-Pyrimethamine

EXPERIMENTAL

Sulfadoxine-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.

Drug: Sulfadoxine-pyrimethamine; Drug: Piperaquine; Drug: Albendazole; Drug: Praziquantel

Sulfadoxine-Pyrimethamine+Piperaquine

EXPERIMENTAL

Sulfadoxine-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.

Drug: Piperaquine; Drug: Albendazole; Drug: Praziquantel

Control

ACTIVE COMPARATOR

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.

Drug: Albendazole; Drug: Praziquantel

Interventions

Sulfadoxine-pyrimethamine DRUG

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

Also known as: Fansidar

Sulfadoxine-Pyrimethamine

Piperaquine DRUG

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.

Sulfadoxine-Pyrimethamine; Sulfadoxine-Pyrimethamine+Piperaquine

Albendazole DRUG

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.

Control; Sulfadoxine-Pyrimethamine; Sulfadoxine-Pyrimethamine+Piperaquine

Praziquantel DRUG

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.

Control; Sulfadoxine-Pyrimethamine; Sulfadoxine-Pyrimethamine+Piperaquine

Eligibility Criteria

• Age: 5 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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, ...)

Sponsors & Collaborators

• Universiteit Antwerpen: lead
• Fund for Scientific Research, Flanders, Belgium: collaborator
• University of Kinshasa: collaborator

Study Sites (1)

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

Kinshasa, Kinshasa Province, Republic of the Congo

Location

Related Publications (1)

• 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.

  PMID: 24063608 DERIVED

MeSH Terms

Conditions

Malaria; Schistosomiasis

Interventions

fanasil, pyrimethamine drug combination; piperaquine; Albendazole; Praziquantel

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Trematode Infections; Helminthiasis

Intervention Hierarchy (Ancestors)

Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Isoquinolines

Study Officials

• Junior Matangila, MD

  University of Kinshasa

  PRINCIPAL INVESTIGATOR

• Pascal Lutumba, MD PhD

  University of Kinshasa

  STUDY DIRECTOR

• Joachim Doua, MD

  Universiteit Antwerpen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: November 3, 2012
• First Posted: November 7, 2012
• Study Start: November 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: February 4, 2014

Record last verified: 2014-02

Locations

RE (1)